FDA Adverse Event
Death
Summary report: N
MP50 INTELLIVUE PATIENT MONITOR
MDR report key: 1981136
·
Received February 1, 2011
Report
- Report Number
- 9610816-2011-00064
- Event Type
- Death
- Date Received
- February 1, 2011
- Report Date
- January 31, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER STATED THAT THEIR MP50 FAILED TO PROVIDE ANY AUDIO ALARM WHEN A PT DEATH OCCURRED WHILE BEING MONITORED. BASED ON THE INITIAL INFO RECEIVED FROM THE CUSTOMER, THE STAFF STATES THAT THEY WERE MONITORING BY SP02 PROBE AND NO OTHER MEANS. NOTE THAT, IF THE SENSOR WAS REMOVED FROM THE PT, ONLY BLUE INOPS AND NO ALARMS ARE TO BE PRODUCED PER DESIGN AND INTENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEIR MP50 FAILED TO PROVIDE ANY AUDIO ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP50 INTELLIVUE PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | M8004A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |