MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-19 for CEILING SUSPENDED RADIATION SHIELD SUPPORT 062301 manufactured by Philips Medical Systems.
[21605157]
The support post for the radiation protection shield broke, causing radiation shield and support arm to fall. Mfr will be replacing the support post.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000396 |
| MDR Report Key | 13769 |
| Date Received | 1994-05-19 |
| Date of Report | 1994-03-30 |
| Date of Event | 1994-03-22 |
| Date Added to Maude | 1994-06-06 |
| 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 | CEILING SUSPENDED RADIATION SHIELD SUPPORT |
| Product Code | EAK |
| Date Received | 1994-05-19 |
| Catalog Number | 062301 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13767 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | SHELTON CT 06484 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-05-19 |