FDA Adverse Event
Death
Summary report: N
MP20 INTELLIVUE PATIENT MONITOR
MDR report key: 1689100
·
Received May 10, 2010
Report
- Report Number
- 9610816-2010-00142
- Event Type
- Death
- Date Received
- May 10, 2010
- Report Date
- May 6, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED AND THE NURSES WERE UNCERTAIN IF THE MONITOR WAS SWITCHED OFF. BASED ON THE IMMEDIATE AVAILABLE INFORMATION, THE HOSPITAL'S BIOMED TESTED THE ALARMS WITH A SIMULATOR AND FOUND NO FAULTS. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT REMAINS UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B) (4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED, AND THE NURSES WERE UNCERTAIN IF THE MONITOR WAS SWITCHED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP20 INTELLIVUE PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |