MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-14 for INTEGRIS CATH LAB SYSTEM manufactured by Siemens Medical Systems.
[18594]
A svc tech was repairing the cath lab system. It was reported to svc that fluoro was "staying on. " while tech was checking the fluoro foot switch (system not on at this time), a nurse came into the room and placed a cine film canister not the cine camera. This caused the system to immediately produce cine x-ray. Both the tech and nurse were temporarily exposed as neither were wearing lead. The tech put on lead and went back into the room to find that the cine foot switch was the cause of the problem, not fluoro. Failure mode is such that the plastic actuators in foot switch broke off and caused the activation. This has occurred on more than one occasion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009098 |
| MDR Report Key | 33000 |
| Date Received | 1996-05-14 |
| Date of Report | 1996-05-13 |
| Date of Event | 1996-05-11 |
| Date Added to Maude | 1996-05-20 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | INTEGRIS CATH LAB SYSTEM |
| Generic Name | CATH LAB SYSTEM |
| Product Code | IZJ |
| Date Received | 1996-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34317 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS |
| Manufacturer Address | ISELIN NJ 08839 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-14 |