MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-14 for PUCK FILM CHANGE manufactured by Siemens Medical Systems.
[19173329]
The film receiving cassette jammed two times. A spare cassette was then implemented and the procedure was resumed. The repair man responded within a few hours and indicated repairs had been made however rptr may need a new cassette. Mfr will assess and advise.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000183 |
| MDR Report Key | 10606 |
| Date Received | 1993-12-14 |
| Date of Report | 1993-07-01 |
| Date of Event | 1993-06-25 |
| Date Added to Maude | 1993-12-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUCK FILM CHANGE |
| Product Code | KPX |
| Date Received | 1993-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10606 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS |
| Manufacturer Address | ISELIN NJ 08830 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1993-12-14 |