FDA Adverse Event
Death
Summary report: N
MP 70 INTELLIVUE PATIENT MONITOR
MDR report key: 1120543
·
Received August 11, 2008
Report
- Report Number
- 9610816-2008-00022
- Event Type
- Death
- Date Received
- August 11, 2008
- Date of Event
- July 10, 2008
- Report Date
- July 14, 2008
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHILIPS IS IN THE PROCESS OF OBTAINING MORE INFO CONCERNING THIS EVENT AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PT WITH AN IMPLANTED PACER, EXPIRED. HOWEVER, THE MONITOR STILL SHOWED A HEART RATE OF 60 AND DID NOT ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP 70 INTELLIVUE PATIENT MONITOR | PATIENT MONITOR WITH PORTAL TECHNOLOGY | MHX | PHILIPS MEDICAL SYSTEMS | M8007A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death |