FDA Adverse Event
Malfunction
Summary report: N
CAREEVENT REL A.0
MDR report key: 9785167
·
Received March 4, 2020
Report
- Report Number
- 1218950-2020-01446
- Event Type
- Malfunction
- Date Received
- March 4, 2020
- Report Date
- February 21, 2020
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MSX
- PMA / PMN Number
- K142935
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
WHILE ONSITE PERFORMING AN ALARM REVIEW WITH THE CUSTOMER, THE PHILIPS CLINICAL APPLICATION SPECIALIST (CAS) NOTED A DIFFERENCE BETWEEN THE NUMBER OF ALARMS LOGGED BETWEEN THE PHILIPS INTELLIVUE INFORMATION CENTER (PIIC) AND THE CAREEVENT. NO ADVERSE EVENT INVOLVING PATIENT OR USER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253482 | CAREEVENT REL A.0 | CARDIAC MONITOR | MSX | PHILIPS MEDICAL SYSTEMS | 866435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |