MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for 30IN (76CM) DISPOSABLE CUFF W/PLC - DP, SB 60707010500 manufactured by Zimmer Surgical, Inc..
[186712454]
This event has been recorded by zimmer biomet under (b)(4). Once an investigation of the device is completed, a follow-up/final report will be submitted. (b)(6)
Patient Sequence No: 1, Text Type: N, H10
[186712455]
It was reported that cuff leak was detected upon connecting the disposable cuff from packaging. There was no harm, no medical intervention, and no delay. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00305 |
| MDR Report Key | 9865165 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-23 |
| 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 | 30IN (76CM) DISPOSABLE CUFF W/PLC - DP, SB |
| Generic Name | TOURNIQUET, PNEUMATIC |
| Product Code | KCY |
| Date Received | 2020-03-23 |
| Catalog Number | 60707010500 |
| Lot Number | 32902291 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-23 |