MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for DUO FLUID CART N/A ULDU100 manufactured by Zimmer Surgical, Inc..
[91075179]
This event has been recorded by zimmer biomet under (b)(4). Customer has indicated that the product is in process of being returned to an external contractor for investigation. Once the investigation has been completed, a follow up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[91075180]
It was reported that the unit had a burning smell along with other unspecified issues. The event occurred during cleaning. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2017-00795 |
| MDR Report Key | 6979031 |
| Date Received | 2017-10-26 |
| Date of Report | 2017-12-22 |
| Date of Event | 2017-10-24 |
| Date Mfgr Received | 2017-12-22 |
| Device Manufacturer Date | 2013-05-21 |
| Date Added to Maude | 2017-10-26 |
| 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 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DUO FLUID CART |
| Generic Name | WASHER OF BODY WASTE RECEPTACLES |
| Product Code | FLH |
| Date Received | 2017-10-26 |
| Model Number | N/A |
| Catalog Number | ULDU100 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-26 |