MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-01-12 for BELIMED CS720 manufactured by Belimed Gmbh.
[15859915]
A sterile processing department operator was using a belimed cs720 cart washer. The doors for the cart washer are closed by pressing and holding two buttons simultaneously the entire time the doors are closing. When the operator pressed and held these two buttons, a cart got stuck in between the two doors. The operator then pressed and held the two buttons with one hand while pushing the cart into the wash chamber with the other hand. The doors then closed on the operator's arm causing an injury. The operator's manual states the following: "if you must be inside the wash chamber for any reason, press the emergency stop push-button inside the chamber. This will prevent any operation of the washer. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043640-2012-00001 |
| MDR Report Key | 2501431 |
| Report Source | 05,07 |
| Date Received | 2012-01-12 |
| Date of Report | 2012-01-04 |
| Date of Event | 2011-12-14 |
| Date Facility Aware | 2011-12-14 |
| Report Date | 2012-01-04 |
| Date Reported to Mfgr | 2011-12-15 |
| Date Mfgr Received | 2011-12-15 |
| Date Added to Maude | 2012-03-26 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Street | 2284 CLEMENTS FERRY ROAD |
| Manufacturer City | CHARLESTON SC 29492 |
| Manufacturer Country | US |
| Manufacturer Postal | 29492 |
| Manufacturer G1 | BELIMED DEUTSCHLAND GMBH |
| Manufacturer Street | EDISONSTRASSE 7-A |
| Manufacturer City | MUEHLDORF AM INN 84453 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 84453 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BELIMED |
| Generic Name | WASHER OF BODY WASTE RECEPTACLES |
| Product Code | FLH |
| Date Received | 2012-01-12 |
| Model Number | CS720 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BELIMED GMBH |
| Manufacturer Address | MUEHLDORF GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-01-12 |