MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-02 for 120 CART WASHER manufactured by Steris Canada Corporation.
[5119146]
The user facility reported their washer was leaking vapor which triggered the fire alarm. No evacuations were reported. The fire department was not dispatched to the user facility. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[12684611]
A steris field service technician arrived onsite, inspected the unit, and identified the unit's door needed minor adjustments. The technician adjusted the door latches, ran several test cycles, and confirmed the unit to be operating according to specification. Upon further investigation, the technician was informed that the customer had opened the washer door before the washer's drying cycle had completed. Vapor was released from the unit, rose to the ceiling, and triggered the fire alarm. The operator manual states, "except for emergency, do not open door when cycle is in progress. " also, "drying (vapor removal)- air from chamber is circulated, at a high velocity, through a steam heat exchanger and back to chamber for time interval selected (9 minutes maximum). When phase time expires, unload indicator light glows on main control panel. On unload-side control panel, green in use light goes off and red unload light comes on. Note: on control plate vapor removal light goes on when drying phase is being performed. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2015-00001 |
| MDR Report Key | 4377596 |
| Report Source | 06 |
| Date Received | 2015-01-02 |
| Date of Report | 2015-01-02 |
| Date of Event | 2014-12-04 |
| Date Mfgr Received | 2014-12-04 |
| Date Added to Maude | 2015-01-02 |
| 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 | 2015-01-02 |
| 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 | 1. Other | 2015-01-02 |