MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-18 for ARRITECHNO/PHILIPS XRAY SYSTEM * 9879231109B manufactured by Phillips Medical Systems.
[16792905]
Cine film canister connected to cinc machine in cardiac catheterization lab. Pt was on table when technician went to advance film, canister fell off machine and hit the pt on his head. Technician heard film magazine click into place and locked into in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 150220 |
| MDR Report Key | 150220 |
| Date Received | 1998-02-18 |
| Date of Report | 1998-02-17 |
| Date of Event | 1998-02-14 |
| Report Date | 1998-02-17 |
| Date Added to Maude | 1998-02-24 |
| 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 | ARRITECHNO/PHILIPS XRAY SYSTEM |
| Generic Name | CINE FILM MAGAZINE (ARRITECHNO) |
| Product Code | IXX |
| Date Received | 1998-02-18 |
| Model Number | * |
| Catalog Number | 9879231109B |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 146366 |
| Manufacturer | PHILLIPS MEDICAL SYSTEMS |
| Manufacturer Address | 710 BRIDGEPORT AVE. P.O. BOX 860 SHELTON CT 064840917 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1998-02-18 |