FDA Adverse Event
Malfunction
Summary report: N
OBTV SERVER
MDR report key: 2549767
·
Received April 17, 2012
Report
- Report Number
- 9610816-2012-00183
- Event Type
- Malfunction
- Date Received
- April 17, 2012
- Report Date
- April 6, 2012
- Manufacturer
- PHILIPS MED SYSTEMS
- Product Code
- HFM
- PMA / PMN Number
- K970456
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE ALARMS WERE NOT FUNCTIONING ON THEIR DEVICES. NO PT HARM WAS REPORTED. DUE TO THE ALLEGATION THAT THE ALARMS DID NOT WORK AND SINCE A USER MIGHT NOT BE AWARE THAT THE ALARMS ARE NOT FUNCTIONING, PHILIPS REPORTING THIS INCIDENT. BASED ON THE INITIAL INFO PROVIDED, PHILIPS CONSIDERS THAT THIS IS NOT A MALFUNCTION OF THE DEVICE. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT 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 THE ALARMS WERE NOT FUNCTIONING ON THEIR DEVICES. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTV SERVER | HFM | PHILIPS MED SYSTEMS | M1383D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |