MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for ZIMMER MOTOR SYSTEM 115V 00900125 manufactured by Zimmer Dental.
[181969611]
Doctor reports that when he hits the foot pedal of the 00900125, the temperature gauge shows immediately and it does not heat at all. The malfunction was discovered during a procedure. As a result of the device malfunction, the procedure could not be completed and the patient was sutured up and sent home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00391 |
| MDR Report Key | 9746882 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-06 |
| Date Facility Aware | 2020-02-06 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-02-24 |
| Date Added to Maude | 2020-02-24 |
| 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 Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER MOTOR SYSTEM 115V |
| Generic Name | DRILL UNIT |
| Product Code | DZA |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-17 |
| Catalog Number | 00900125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER DENTAL |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-24 |