MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-07 for ZIMMER ATS4000 manufactured by Zimmer.
[42505741]
During use of the tourniquet, the device screen malfunctioned and device at end of case had to be deflated manually.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061608 |
| MDR Report Key | 5569957 |
| Date Received | 2016-04-07 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-03-29 |
| Date Added to Maude | 2016-04-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIMMER |
| Generic Name | TOURNIQUET AUTOMATIC |
| Product Code | DRP |
| Date Received | 2016-04-07 |
| Returned To Mfg | 2016-04-07 |
| Model Number | ATS4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Manufacturer Address | WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-07 |