FDA Adverse Event
Malfunction
Summary report: N
VM6
MDR report key: 1052836
·
Received May 23, 2008
Report
- Report Number
- 1218950-2008-00284
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Report Date
- April 30, 2008
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVOLVED DEVICE WAS RETURNED TO PHILIPS FOR BENCH REPAIR. THE FAILED SPEAKER WAS REPLACED AND THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER. THE DEVICE IS CONSIDERED FULLY OPERATIONAL.
Description of Event or Problem · 1
THE CUSTOMER CALLED THE REMOTE TECHNICAL ASSISTANCE CENTER AND STATED, THERE WAS NO VOLUME COMING FROM THE SPEAKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VM6 | COMPACT PORTABLE PATIENT MONITORS | DRT | PHILIPS MEDICAL SYSTEMS | 863064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |