FDA Adverse Event
Death
Summary report: N
MP50 INTELLIVUE PATIENT MONITOR
MDR report key: 2474584
·
Received February 27, 2012
Report
- Report Number
- 9610816-2012-00081
- Event Type
- Death
- Date Received
- February 27, 2012
- Date of Event
- February 24, 2012
- Report Date
- February 24, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS-DUP
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT A PT DEATH OCCURRED WHILE BEING MONITORED WITH AN INTELLIVUE MP50 MONITOR. IT WAS REPORTED THAT THE SPO2 SENSOR BECAME DISCONNECTED AND THE MONITOR DID NOT ALARM TO ALERT THE USER. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT 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 A PT DEATH OCCURRED WHILE BEING MONITORED WITH AN INTELLIVUE MP50 MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP50 INTELLIVUE PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS-DUP | M8004A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |