FDA Adverse Event
Malfunction
Summary report: N
OBTV CLIENT
MDR report key: 1833311
·
Received September 10, 2010
Report
- Report Number
- 9610816-2010-00358
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Report Date
- August 10, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- HGM
- PMA / PMN Number
- K970456
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THERE WERE MISSING ALERTS AND MISSING AUDIO. THE INITIAL INVESTIGATION REVEALED THAT A SUPER-USER AT THE HOSPITAL HAD DISABLE THE ALARMS. 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 SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WERE MISSING ALERTS AND MISSING AUDIO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTV CLIENT | HGM | PHILIPS MEDICAL SYSTEMS | M1382E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |