MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-16 for HAMO RELIANCE VISION MULTI-CHAMBER WASHER manufactured by Steris Canada Corporation.
[185931395]
A steris service technician arrived onsite to inspect the washer. Review of the washer's cycle tapes revealed that a "drying temp. Too high" alarm had occurred while a cycle was running prior to the reported event. This alarm occurs to alert the user that the drying element is overheating and that the unit should be taken out of service. The technician inspected the unit and found the root cause of the reported event is attributed to the drying element. The drying element overheated resulting in the reported event. The washer was installed in 2013 and is under steris service agreement for maintenance activities. The last maintenance was performed on (b)(6) 2020. No issues with the function or operation of the washer were identified at that time; the unit was operating according to specification. The unit has been removed from service pending repairs. A follow-up mdr will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[185931396]
The user facility reported that smoke was coming from their reliance vision multi-chamber washer. User facility personnel immediately shut power off to the unit and the smoking stopped. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2020-00012 |
| MDR Report Key | 9836174 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 3927453 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, GIC 8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAMO RELIANCE VISION MULTI-CHAMBER WASHER |
| Generic Name | WASHER |
| Product Code | MEC |
| Date Received | 2020-03-16 |
| 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, GIC 8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |