MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-25 for TOCO TRANSDUCER M1355A-61652 * manufactured by Philips Medical Systems, Inc..
[16364442]
Pins on connector are too soft, bends easily, then fails to operate. Follow-up: unit removed from service, awaiting replacement from philips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 553895 |
| MDR Report Key | 553895 |
| Date Received | 2004-10-25 |
| Date of Report | 2004-09-22 |
| Date of Event | 2004-09-22 |
| Report Date | 2004-09-22 |
| Date Reported to FDA | 2004-10-25 |
| Date Added to Maude | 2004-11-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOCO TRANSDUCER |
| Generic Name | TOCO TRANSDUCER |
| Product Code | JOP |
| Date Received | 2004-10-25 |
| Model Number | M1355A-61652 |
| Catalog Number | * |
| Lot Number | 2B |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 2 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 543523 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-25 |