FDA Adverse Event
Death
Summary report: N
INTELLIVUE INFORMATION CENTER CLIENT
MDR report key: 2091109
·
Received May 4, 2011
Report
- Report Number
- 1218950-2011-01109
- Event Type
- Death
- Date Received
- May 4, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 11, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MHX
- PMA / PMN Number
- K081983
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER HAS REQUESTED ASSISTANCE IN OBTAINING RETROSPECTIVE DATA FOLLOWING A DEATH. THERE WAS NO ALLEGATION OF A MALFUNCTION IN MONITORING, OR ANY INDICATION THAT THE DEVICE WAS A FACTOR IN THE DEATH. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING 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 HAS REQUESTED ASSISTANCE IN OBTAINING RETROSPECTIVE DATA FOLLOWING A DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE INFORMATION CENTER CLIENT | MHX | PHILIPS HEALTHCARE | 865094 (M3155) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |