FDA Adverse Event
Death
Summary report: N
INTELLIVUE INFORMATION CENTER CLIENT
MDR report key: 2142473
·
Received June 21, 2011
Report
- Report Number
- 1218950-2011-01738
- Event Type
- Death
- Date Received
- June 21, 2011
- Report Date
- June 13, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MHX
- PMA / PMN Number
- K081983
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED. THE CUSTOMER STATED THAT THEY THOUGHT THEY MIGHT HAVE MISSED AN ALARM AND WANTED TO HELP REVIEWING DATA AS THE TELE TECH DISCHARGED AND REMOVED DATA. THERE WAS NO ALLEGATION OF A MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 PATIENT DEATH OCCURRED AND THEY BELIEVE THEY MISSED AN ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE INFORMATION CENTER CLIENT | MHX | PHILIPS HEALTHCARE - ANDOVER | 865094 (M3155) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |