MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-06 for CLEAR-PB MOBILE BARRIERS 56-604 * manufactured by Fluke Biomedical (formerly Nuclear Associates).
[2631809]
The patient was undergoing coronary angiography. The attending physician was walking across the procedure room in order to insert some documents into the patient's chart. Since fluoroscopy was ongoing, he was moving the mobile x-ray shield across the room so that he would remain behind it. Just after he let go, the upper portion of the window snapped off just above the vertical mounts on both sides. The cracked edge was smooth but not sharp like glass. The piece that fell to the floor did not shatter nor strike anyone or anything that would have compromised the procedure. Staff fortunately saved the two parts of the broken window. It's made of plastic, not glass so the part that fell didn't shatter. The device is considered a radiation safety device by the manufacturer. My opinion is that there was a notch near one of the side support channels and that the continued flexing and handling of the unsupported upper portion of the window over a long period of time resulted in a crack growing from the notch until this catastrophic event occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2485616 |
| MDR Report Key | 2485616 |
| Date Received | 2012-03-06 |
| Date of Report | 2012-03-06 |
| Date of Event | 2012-02-27 |
| Report Date | 2012-03-06 |
| Date Reported to FDA | 2012-03-06 |
| Date Added to Maude | 2012-03-09 |
| 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 | CLEAR-PB MOBILE BARRIERS |
| Generic Name | SHIELD, X-RAY, MOBILE |
| Product Code | IWS |
| Date Received | 2012-03-06 |
| Model Number | 56-604 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Age | 11 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FLUKE BIOMEDICAL (FORMERLY NUCLEAR ASSOCIATES) |
| Manufacturer Address | 6920 SEAWAY BLVD EVERETT WA 98203 US 98203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-06 |