MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ATS2200TS WITH HOSES-ES; TOURNIQUET, PNEUMATIC

Model Number N/A

Device Problems Deflation Problem (1149); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that before surgery the tourniquet fills and decreases the air hose without being touched.The pressure changes by itself.No patient involved.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d4, g4, g7, h2, h3, h4, h6, h8, h10.Review of the most recent repair record determined the power supply failed.The power supply was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.

Event Description

No additional event information available.

• Brand Name: ATS2200TS WITH HOSES-ES
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10188682
• MDR Text Key: 196232118
• Report Number: 0001526350-2020-00550
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 60220030112
• Device Lot Number: 64572491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1