FDA Adverse Event
Death
Summary report: N
INTELLIVUE INFORMATION CENTER
MDR report key: 1655769
·
Received April 7, 2010
Report
- Report Number
- 1218950-2010-00458
- Event Type
- Death
- Date Received
- April 7, 2010
- Report Date
- March 31, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K081983
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT NO ALARMS WERE PROVIDED AT THE BEDSIDE AND CENTRAL STATION FOR A PATIENT DEATH. POST INCIDENT TESTING OF ALL INVOLVED PHILIPS DEVICES SHOWED THAT THEY WERE ALL PERFORMING AS INTENDED AND SPECIFIED. ALARMS WERE SHOWN TO HAVE OCCURRED THROUGHOUT THE TIME IN QUESTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED. (B) (4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT NO ALARMS WERE PROVIDED AT THE BEDSIDE AND CENTRAL STATION FOR A PATIENT DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE INFORMATION CENTER | MHX | PHILIPS MEDICAL SYSTEMS | 862067 (M3150B) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |