MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-27 for 120 CART WASHER manufactured by Steris Canada Corporation.
[20298142]
The user facility expressed dissatisfaction with their 120 cart washer.
Patient Sequence No: 1, Text Type: D, B5
[20505497]
Investigation of this event is currently in process. A follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[25235433]
A steris service technician inspected the washer and found the incorrect model of illumination bulb installed and not functioning. In addition, he found a blown control fuse. The technician removed and replaced the bulb and blown fuse. The technician further inspected the washer and found several components were not functioning properly, specifically the motor fan, tank heater coil and water booster tank. The washer is approximately 17 years old and is serviced and maintained by the user facility. Steris recommended to the user facility that the washer be replaced or be taken out of service due to the technician's findings and age of the unit. The user facility continues to use the washer until a decision on steris' recommended actions are made.
Patient Sequence No: 1, Text Type: N, H10
[25235434]
The user facility further reported that a ready light is not illuminating. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2014-00045 |
| MDR Report Key | 3900571 |
| Report Source | 06 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-06-27 |
| Date of Event | 2014-06-06 |
| Date Mfgr Received | 2014-06-06 |
| Date Added to Maude | 2014-07-18 |
| 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 | 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 | 120 CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2014-06-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2014-06-27 |