MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-02 for ATS 2000 manufactured by Zimmer Surgical, Inc..
[173291892]
During surgery, patient started bleeding while tourniquet (#43934) pressure was on at 240mmhg. After switching the red tourniquet cords to the blue tourniquet cords, bleeding stopped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9537832 |
| MDR Report Key | 9537832 |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-09-19 |
| Report Date | 2019-12-16 |
| Date Reported to FDA | 2019-12-16 |
| Date Reported to Mfgr | 2020-01-02 |
| Date Added to Maude | 2020-01-02 |
| 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 | 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 | ATS 2000 |
| Generic Name | TOURNIQUET, PNEUMATIC |
| Product Code | KCY |
| Date Received | 2020-01-02 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 56 EAST BELL DRIVE WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-02 |