MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for HAMO LS2000 WASHER manufactured by Steris Gmbh.
[28159461]
A steris service technician inspected the washer and found it to be operating properly; no issues were noted. The technician could not find any leaks as initially reported by the user facility; the washer was returned to service. The technician observed that the floor drain located on the "dirty side" of the washer was backing up causing water to accumulate on the floor. The technician replaced the drain valve on the washer as a precaution as it may have sustained damage from the floor drain backing up. The technician has made user facility personnel aware of the floor drain backing up on several occasions as this is not the first occurrence of the floor drain backing up. The user facility is responsible for ensuring the floor drain is operating properly. Steris is not responsible for properly servicing and maintaining the floor drain.
Patient Sequence No: 1, Text Type: N, H10
[28159462]
The user facility reported that their washer was leaking water. An employee slipped on water subsequently hitting her knee on a door jam. The employee applied ice and returned to work. No medical treatment was sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527821-2015-00001 |
| MDR Report Key | 5138265 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-10-08 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2015-09-08 |
| Date Added to Maude | 2015-10-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HAMO LS2000 WASHER |
| Generic Name | WASHER |
| Product Code | LDS |
| Date Received | 2015-10-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS GMBH |
| Manufacturer Address | BIELSTRASSE 76 2542 PIETERLEN PIETERLEN, SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |