MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-16 for 1227 CART WASHER manufactured by Steris Canada Corporation.
[6050605]
The user facility reported via medwatch (b)(4) that employees are sustaining hand injuries when removing carts from the cart washer.
Patient Sequence No: 1, Text Type: D, B5
[13770642]
The user facility medwatch also stated that employee's hands are getting caught between the cart and door when unloading. No handles are attached. A steris service technician inspected the washer and case cart and found them to be operating properly. No issues were noted. The washer and case cart were returned to service and no additional issues have been reported. Contrary to the facility report, the technician confirmed the case cart's handles were attached to the unit. Instead of utilizing the case cart handles the employee grabbed the top left and right side of the cart to remove it from the washer. In the process of removing the case cart the employee injured her finger between the washer door and case cart. The employee wore a soft brace and missed no time from work. The user facility reported that employees were sustaining injuries, however steris was made aware of only one employee injury in relation to the reported event. Handles on the case cart are located on one side of the case. The handles on the case cart should be facing the unload side for proper unloading after a washing cycle. The user facility could not confirm the position of the case cart at the time of the reported event and therefore it is possible the employee could not see the handles to ensure proper removal. The employee who sustained the injury was new to the department. Steris performed in-service training on the proper use and handling of the case cart and washer. The case cart subject of the reported event is not serviced or maintained by steris.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2015-00044 |
| MDR Report Key | 4918604 |
| Report Source | 06 |
| Date Received | 2015-07-16 |
| Date of Report | 2015-07-16 |
| Date of Event | 2015-06-05 |
| Date Mfgr Received | 2015-06-22 |
| Date Added to Maude | 2015-07-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, QUEBEC GIC8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1227 CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2015-07-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CANADA CORPORATION |
| Manufacturer Address | 490 ARMAND-PARIS QUEBEC, QUEBEC GIC8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-16 |