MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-18 for 220 CART WASHER manufactured by Steris Canada Corporation.
[3653953]
The user facility reported that steam escaped from their 220 cart washer when the door was opened after a completed cycle. The sprinkler system initiated. No procedural delays or cancellations have been reported. No injuries to hospital staff or patients were reported.
Patient Sequence No: 1, Text Type: D, B5
[11040993]
A steris service technician arrived on site to inspect the unit. The technician found the unit experienced a control failure after the steam injection phase. This failure caused the washer to indicate the cycle was completed, when in fact, the washer failed to perform the last cycle, which is the dry phase. As a result, steam was present when the operator opened the door to unload items. The sprinkler system did initiate. The sprinkler head near the washer initiated, covering the floor surrounding the front of the washer in the clean spd room. Hospital security responded to the event; no emergency services were contacted. The technician found the intermediary pc control board had corrosion on the circuits. This was attributed to prolonged exposure to moisture. The technician replaced the pc control board and performed a test cycle. The unit was confirmed operational and returned to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2013-00084 |
| MDR Report Key | 3232596 |
| Report Source | 06 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-07-17 |
| Date of Event | 2013-06-17 |
| Date Mfgr Received | 2013-06-17 |
| Date Added to Maude | 2013-10-09 |
| 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 | 220 CART WASHER |
| Generic Name | WASHER |
| Product Code | LDS |
| Date Received | 2013-07-18 |
| 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 | 2013-07-18 |