MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-09 for TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE TPSS100 manufactured by Dornoch.
[133086683]
This event has been documented under zimmer biomet complaint number (b)(4). The device is being evaluated by an external contractor and investigation is in process. Once the investigation is completed, a follow up medwatch will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[133086684]
It was reported that the unit would not power on and there was an electrical burning smell coming from unit. The event occurred during cleaning. No adverse events have been reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001954182-2019-00004 |
| MDR Report Key | 8232417 |
| Date Received | 2019-01-09 |
| Date of Report | 2019-02-15 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2019-02-14 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2019-01-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | DORNOCH |
| Manufacturer Street | 200 NORTHWEST PARKWAY |
| Manufacturer City | RIVERSIDE MO 64150 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64150 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE |
| Generic Name | WASHER OF BODY WASTE RECEPTACLES |
| Product Code | FLH |
| Date Received | 2019-01-09 |
| Catalog Number | TPSS100 |
| Lot Number | 0021788 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNOCH |
| Manufacturer Address | 200 NORTHWEST PARKWAY RIVERSIDE MO 64150 US 64150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-09 |