MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for TOURNIQUET-ATS 4000TS manufactured by Zimmer Surgical Inc..
[174280269]
Right arm tourniquet was inflated at 1240 and deflated at 1305. At 1416, the tourniquet was noted to be inflated to 250 mm/hg. The tourniquet was not inflated by any team member, but had been inflated for 17 min. Tourniquet removed and taken out of service. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092035 |
| MDR Report Key | 9558146 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-28 |
| Date Added to Maude | 2020-01-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | TOURNIQUET-ATS 4000TS |
| Generic Name | TOURNIQUET, PNEUMATIC |
| Product Code | KCY |
| Date Received | 2020-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-06 |