FDA Adverse Event
Death
Summary report: N
INTELLIVUE INFORMATION CENTER
MDR report key: 1655772
·
Received April 7, 2010
Report
- Report Number
- 1218950-2010-00447
- Event Type
- Death
- Date Received
- April 7, 2010
- Report Date
- April 1, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K081983
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED AND THAT THE PHILIPS DEVICE WAS A FACTOR. 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. (B) (4)
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED AND THAT THE PHILIPS DEVICE WAS A FACTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE INFORMATION CENTER | MHX | PHILIPS MEDICAL SYSTEMS | M3154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |