MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-13 for 1200 RELIANCE CART WASHER manufactured by Steris Canada Corporation.
[2973541]
The user facility reported water leaking from their reliance cart washer. The water reportedly went out of the room where the device is located and into the department surrounding the device. There are no reports of injury, delayed/cancelled procedures or property damage.
Patient Sequence No: 1, Text Type: D, B5
[10164701]
A steris service technician inspected the washer and found that the unit drains into a pit via a 4" pvc line. The pvc line shifted, causing the water to splash out of the pit during cycles. The service technician anchored the pvc line to the pit. He tested the unit with no further issue and returned the device to service.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 9680353-2012-00072 |
MDR Report Key | 2743648 |
Report Source | 06 |
Date Received | 2012-09-13 |
Date of Report | 2012-09-13 |
Date of Event | 2012-08-20 |
Date Mfgr Received | 2012-08-20 |
Date Added to Maude | 2013-01-02 |
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 LINDSEY MCGOWAN |
Manufacturer Street | 5960 HEISLEY ROAD |
Manufacturer City | MENTOR OH 44060 |
Manufacturer Country | US |
Manufacturer Postal | 44060 |
Manufacturer Phone | 4403927519 |
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 | 1200 RELIANCE CART WASHER |
Generic Name | WASHER |
Product Code | LDS |
Date Received | 2012-09-13 |
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 | 2012-09-13 |