Device product
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.
Z-0544-2021
Product summary
- Event
- Event 86848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 total: 2 units US ; 14 OUS
- Official record key
device-enforcement:Z-0544-2021
Official wording
Reason: Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
Code information: Serial Numbers: US: DE73607502 DE73607498 OUS: System Serial Number DE95038935 DE73608191 DE73608209 DE73601727 DE73604240 DE73601547 DE73601596 DE73604182 DE83617535 DE73608259 DE83617500 DE83617522 DE73601651
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.
Derived failure modes
-
Unknown
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.