MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-10 for ATS 500 TOURNIQUET SYSTEM manufactured by Zimmer Patient Care Division.
[16473281]
Tourniquet inflated. During administration of bier block blanching replaced by return of blood flow to arm. Patient had adequate bier block but hemostasis not present with tourniquet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 156254 |
| MDR Report Key | 156254 |
| Date Received | 1998-03-10 |
| Date of Report | 1998-01-15 |
| Date of Event | 1998-01-13 |
| Date Facility Aware | 1998-01-14 |
| Report Date | 1998-01-15 |
| Date Reported to Mfgr | 1998-01-16 |
| Date Added to Maude | 1998-03-18 |
| 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 | ATS 500 TOURNIQUET SYSTEM |
| Generic Name | TOURNIQUET |
| Product Code | DRP |
| Date Received | 1998-03-10 |
| Model Number | ATS 500 |
| Catalog Number | NI |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 14 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 152210 |
| Manufacturer | ZIMMER PATIENT CARE DIVISION |
| Manufacturer Address | 200 WEST OHIO AVE. DOVER OH 44622 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-10 |