FDA Adverse Event
Death
Summary report: N
OBTV SW UPGRADES
MDR report key: 1686064
·
Received May 11, 2010
Report
- Report Number
- 9610816-2010-00126
- Event Type
- Death
- Date Received
- May 11, 2010
- Report Date
- April 29, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- HGM
- PMA / PMN Number
- K970456
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THERE WAS AN INFANT DEATH AND THEY ARE QUESTIONING THE MONITORING. BASED ON THE LIMITED INFO, AN ADVERSE EVENT TOOK PLACE AND THE CUSTOMER IS ALLEGING THAT THEIR PHILIPS OBTV DEVICE MIGHT HAVE CONTRIBUTED BECAUSE THE APPEARANCE OF THE MOTHER AND BABY'S TRACE WAS SIMILAR. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO 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 THERE WAS AN INFANT DEATH, AND THEY ARE QUESTIONING THE MONITORING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTV SW UPGRADES | HGM | PHILIPS MEDICAL SYSTEMS | M1384E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DA | Death |