Device product
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
Z-2427-2021
Product summary
- Event
- Event 88361
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,840 units
- Official record key
device-enforcement:Z-2427-2021
Official wording
Reason: Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient
Code information: Lot Y111220-01
Distribution pattern: Worldwide distribution. US Nationwide, Australia, Austria, Bolivia, Canada, Chile, China, Denmark, France, French Polynesia, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Republic of Korea, Malta, Martinique, Mexico, Monaco, Netherlands, Norway, Poland, Spain, Switzerland, Taiwan, United Kingdom, and Uruguay
Derived failure modes
-
Labeling or packaging
incorrect labeling