MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-27 for CART AND UTENSIL WASHER/ DISINFECTOR RELIANCE 130/130L * manufactured by Steris Corporation.
[1974793]
Technician was loading the cart washer and the load doors closed, sealing the technician inside the unit. The technician had to be extracted from the unit by summoned help. ======================manufacturer response for cart and utensil washer/ disinfector, cart and utensil washer/ disinfector (per site reporter)======================an investigative team was sent in to get the information of the incident. The report of findings is not yet available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2116584 |
| MDR Report Key | 2116584 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-05-27 |
| Date of Event | 2011-05-20 |
| Report Date | 2011-05-27 |
| Date Reported to FDA | 2011-05-27 |
| Date Added to Maude | 2011-06-08 |
| 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 | CART AND UTENSIL WASHER/ DISINFECTOR |
| Generic Name | CART AND UTENSIL WASHER/ DISINFECTOR |
| Product Code | FLH |
| Date Received | 2011-05-27 |
| Model Number | RELIANCE 130/130L |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-27 |