MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-08 for ZIMMER ATS 2000 * REF. 60-2000-101 manufactured by Zimmer Patient Care.
[225520]
After self test and calibration, the unit allegedly locked up and could not be changed; deflated, or othewise manually controlled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 320036 |
| MDR Report Key | 320036 |
| Date Received | 2001-03-08 |
| Date of Report | 2000-12-21 |
| Date of Event | 2000-12-21 |
| Report Date | 2000-12-21 |
| Date Reported to Mfgr | 2000-12-21 |
| Date Added to Maude | 2001-03-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER ATS 2000 |
| Generic Name | AUTOMATIC TOURNIQUET SYSTEM |
| Product Code | DRP |
| Date Received | 2001-03-08 |
| Model Number | * |
| Catalog Number | REF. 60-2000-101 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 309562 |
| Manufacturer | ZIMMER PATIENT CARE |
| Manufacturer Address | 200 WEST OHIO AVE. DOVER OH 44622 US |
| Baseline Brand Name | ZIMMER ATS 2000 |
| Baseline Generic Name | AUTOMATIC TOURNIQUET SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | REF. 60-2000-101 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-03-08 |