MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-18 for SCHONANDER-ELEMA AB FILM CHANGER 67-48-167-G019E manufactured by Siemens Medical Systems.
[15445668]
Pt was prepared for arteriogram (pre-op med and iv). Unable to do procedure as film changer malfunctioned. Procedure was rescheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000025 |
| MDR Report Key | 10534 |
| Date Received | 1993-08-18 |
| Date of Event | 1993-08-17 |
| Date Added to Maude | 1993-12-17 |
| 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 |
| 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 | SCHONANDER-ELEMA AB FILM CHANGER |
| Product Code | KPX |
| Date Received | 1993-08-18 |
| Model Number | 67-48-167-G019E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10534 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS |
| Manufacturer Address | ISELIN NJ 08830 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1993-08-18 |