FDA Adverse Event
Malfunction
Summary report: N
TOCO TRANSDUCER
MDR report key: 553895
·
Received October 25, 2004
Report
- Report Number
- 553895
- Event Type
- Malfunction
- Date Received
- October 25, 2004
- Date of Event
- September 22, 2004
- Report Date
- September 22, 2004
- Manufacturer
- PHILIPS MEDICAL SYSTEMS, INC.
- Product Code
- JOP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- LA, US
Narratives
Description of Event or Problem · 1
PINS ON CONNECTOR ARE TOO SOFT, BENDS EASILY, THEN FAILS TO OPERATE. FOLLOW-UP: UNIT REMOVED FROM SERVICE, AWAITING REPLACEMENT FROM PHILIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOCO TRANSDUCER | TOCO TRANSDUCER | JOP | PHILIPS MEDICAL SYSTEMS, INC. | M1355A-61652 | 2B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |