FDA Adverse Event
Death
Summary report: N
INTELLIVUE DATABASE SERVER
MDR report key: 1191552
·
Received October 7, 2008
Report
- Report Number
- 1218950-2008-00530
- Event Type
- Death
- Date Received
- October 7, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 24, 2008
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT, AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER THAT THE PT EXPERIENCED A BRADY AND ASYSTOLE ALARM AND THE CISCO PHONE SYSTEM DID NOT ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE DATABASE SERVER | PHILIPS DATABASE SERVER | MHX | PHILIPS MEDICAL SYSTEMS | 862207(M3154 REL. G) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Death| L |