Device product
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
Z-2750-2020
Product summary
- Event
- Event 85979
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,414 units
- Official record key
device-enforcement:Z-2750-2020
Official wording
Reason: CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.
Code information: Model: 2087075-001 Serial Numbers: SNA20210164SA, SNA20210031SA, SNA20210045SA, SNA20210064SA, SNA20210319SA, SNA20210330SA, SNA20210348SA, SNA20210361SA, SNA20210362SA, SNA20210375SA, SNA20210376SA, SNA20210377SA, SNA20220003SA, SNA20220005SA, SNA20220007SA, SNA20220018SA, SNA20220022SA, SNA20220026SA, SNA20220045SA, SNA20220047SA, SNA18140024SA, SNA18340072SA, SNA18370025SA, SNA18380001SA, SNA18390009SA, SNA18430002SA, SNA18430059SA, SNA18430088SA, SNA18430116SA, SNA19390023SA, SNA19400056SA, SNA19400143SA, SNA19440048SA, SNA19440069SA, SNA19440071SA, SNA19440122SA, SNA19450008SA, SNA19450025SA, SNA19450128SA, SNA19450136SA, SNA19500072SA, SNA19500073SA, SNA19500080SA, SNA19500084SA, SNA19500086SA, SNA19510001SA, SNA19510005SA, SNA19510007SA, SNA19510012SA, SNA19510027SA, SNA19510053SA, SNA19510055SA, SNA19510103SA, SNA20020119SA, SNA20030070SA, SNA20030071SA, SNA20170022SA, SNA20170080SA, SNA20170082SA, SNA20170112SA, SNA20170113SA, SNA20170116SA, SNA20170117SA, SNA20170118SA, SNA20170120SA, SNA20170131SA, SNA20170134SA, SNA20170136SA, SNA20170139SA, SNA20170145SA, SNA20170160SA, SNA20170161SA, SNA20170164SA, SNA20170166SA, SNA20170168SA, SNA20170169SA, SNA20170171SA, SNA20170173SA, SNA20170176SA, SNA20170181SA, SNA20170182SA, SNA20170194SA, SNA20170197SA, SNA20170198SA, SNA20170232SA, SNA20170237SA, SNA20170264SA, SNA20180002SA, SNA20180008SA, SNA20180009SA, SNA20180011SA, SNA20180012SA, SNA20180017SA, SNA20180018SA, SNA20180023SA, SNA20180025SA, SNA20180026SA, SNA20180027SA, SNA20180028SA, SNA20180029SA, SNA20180030SA, SNA20180031SA, SNA20180032SA, SNA20180040SA, SNA20180042SA, SNA20180043SA, SNA20180044SA, SNA20180071SA, SNA20180073SA, SNA20180074SA, SNA20180075SA, SNA20180076SA, SNA20180080SA, SNA20180096SA, SNA20180101SA, SNA20180102SA, SNA20180109SA, SNA20180117SA, SNA20180144SA, SNA20180161SA, SNA20180162SA, SNA20190321SA, SNA20190331SA, SNA18140004SA, SNA18140005SA, SNA18140007SA, SNA18240025SA, SNA18240026SA, SNA18240030SA, SNA18240032SA, SNA18240044SA, SNA18240051SA, SNA18240054SA, SNA18240079SA, SNA18250010SA, SNA18250012SA, SNA18250017SA, SNA18250023SA, SNA18250026SA, SNA18250033SA, SNA18250034SA, SNA18250036SA, SNA18250044SA, SNA18250061SA, SNA18250072SA, SNA18250075SA, SNA18250078SA, SNA18250080SA, SNA18250081SA, SNA18250082SA, SNA18250086SA, SNA18250092SA, SNA18250093SA, SNA18440051SA, SNA18450094SA, SNA18450098SA, SNA18460013SA, SNA18460040SA, SNA18460072SA, SNA18460075SA, SNA18460083SA, SNA18460086SA, SNA18460089SA, SNA18460101SA, SNA19040008SA, SNA19050016SA, SNA19050025SA, SNA19050028SA, SNA19050030SA, SNA19050031SA, SNA19050033SA, SNA19050038SA, SNA19050043SA, SNA19050044SA, SNA19050045SA, SNA19050046SA, SNA19050049SA, SNA19050050SA, SNA19070071SA, SNA19070072SA, SNA19070073SA, SNA19070074SA, SNA19490074SA, SNA19500037SA, SNA19500043SA, SNA19500054SA, SNA19500059SA, SNA19510003SA, SNA20140029SA, SNA20140031SA, SNA20190324SA, SNA19500131SA, SNA20030120SA, SNA20040052SA, SNA20170179SA, SNA20170195SA, SNA20170203SA, SNA20180054SA, SNA20180057SA, SNA20180059SA, SNA20180077SA, SNA20180100SA, SNA20180103SA, SNA20180104SA, SNA20180113SA, SNA20180115SA, SNA20180142SA, SNA20180145SA, SNA20180146SA, SNA20180147SA, SNA20180154SA, SNA20180158SA, SNA20180163SA, SNA20180168SA, SNA20180183SA, SNA20180202SA, SNA20190024SA, SNA20190026SA, SNA20190030SA, SNA20190034SA, SNA20190038SA, SNA20190056SA, SNA20190057SA, SNA20190059SA, SNA20190060SA, SNA20190063SA, SNA20190106SA, SNA20190107SA, SNA20190109SA, SNA20190112SA, SNA20190114SA, SNA20190115SA, SNA20190116SA, SNA20190117SA, SNA20190119SA, SNA20190120SA, SNA20190121SA, SNA20190122SA, SNA20190124SA, SNA20190126SA, SNA20190127SA, SNA20190130SA, SNA20190131SA, SNA20190132SA, SNA20190133SA, SNA20190134SA, SNA20190137SA, SNA20190141SA, SNA20190142SA, SNA20190143SA, SNA20190144SA, SNA20190145SA, SNA20190146SA, SNA20190147SA, SNA20190148SA, SNA20190149SA, SNA20190152SA, SNA20190153SA, SNA20190155SA, SNA20190156SA, SNA20190159SA, SNA20190161SA, SNA20190174SA, SNA20190201SA, SNA20190204SA, SNA20190206SA, SNA20190209SA, SNA20190210SA, SNA20190214SA, SNA20190216SA, SNA20190217SA, SNA20190218SA, SNA20190219SA, SNA20190220SA, SNA20190221SA, SNA20190222SA, SNA20190223SA, SNA20190229SA, SNA20190230SA, SNA20190231SA, SNA20190232SA, SNA20190233SA, SNA20190235SA, SNA20190236SA, SNA20190237SA, SNA20190238SA, SNA20190239SA, SNA20190240SA, SNA20190247SA, SNA20190279SA, SNA20190289SA, SNA20190328SA, SNA20190339SA, SNA20200031SA, SNA20200081SA, SNA20200403SA.
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of MT, NC, TX and WI. The countries of Australia, Austria, Bahrain,Belgium, Bolivia, Brazil ,Canada, Chile, Check Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Russia, Saudi Arabia, Singapore, Saint Martin, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom.
Derived failure modes
-
Unknown
CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.