MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-27 for A.T.S. 2200TS TOURNIQUET W/HOSES (PERSONALIZED PRESSURE¿?) N/A 60220010100 manufactured by Zimmer Surgical, Inc..
[178568596]
(b)(4). The investigation is still in progress. Once the investigation is complete a follow up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[178568597]
It has been reported that the device was intermittently inflating the opposite port while in use. The malfunction occurred during pre-testing before a case. There was no harm to the patient. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00101 |
| MDR Report Key | 9634775 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A.T.S. 2200TS TOURNIQUET W/HOSES (PERSONALIZED PRESSURE¿?) |
| Generic Name | TOURNIQUET, PNEUMATIC |
| Product Code | KCY |
| Date Received | 2020-01-27 |
| Returned To Mfg | 2020-01-10 |
| Model Number | N/A |
| Catalog Number | 60220010100 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-27 |