MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-04-09 for CLEAR-PB MOBILE BARRIERS 56-604 manufactured by Fluke Biomedical.
[2608038]
Customer claims 11 yr old (b)(4) clear pb mobile barrier broke during use. Complaint description as provided in customer supplied 3500a: "event desc: the pt was undergoing coronary angiography. The attending physician was walking across the procedure room in order to insert some documents into the pt's chart. Since fluoroscopy was on going, 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 mfr. " "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
[9954364]
Product was mfg by nuclear associates who was subsequently acquired by fluke biomedical. Customer has been contacted to determine if product is available for investigation. No response received as of apr 5, 2012. F/u report will be submitted when additional info is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921581-2012-00001 |
| MDR Report Key | 2538070 |
| Report Source | 07 |
| Date Received | 2012-04-09 |
| Date of Report | 2012-03-26 |
| Date of Event | 2012-02-27 |
| Date Mfgr Received | 2012-03-26 |
| Date Added to Maude | 2012-09-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | 6920 SEAWAY BLVD. |
| Manufacturer City | EVERETT WA 98203 |
| Manufacturer Country | US |
| Manufacturer Postal | 98203 |
| Manufacturer Phone | 4404982579 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEAR-PB MOBILE BARRIERS |
| Generic Name | SHIELD, X-RAY MOBILE |
| Product Code | KPY |
| Date Received | 2012-04-09 |
| Model Number | 56-604 |
| Catalog Number | 56-604 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FLUKE BIOMEDICAL |
| Manufacturer Address | 6920 SEAWAY BLVD. EVERETT WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-09 |