MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ATS 1200 W/HOSES, W/ENGLISH MANUAL; TOURNIQUETS, PNEUMATIC

Model Number N/A

Device Problems Device Alarm System (1012); Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).A follow up/final report will be submitted once the investigation is complete.

Event Description

It was reported that the ats 1200 was spontaneously decompressing at times and it was alarming.The reported issue was noticed before surgery, there was no harm to the patient or staff or impact to the procedure as a result of the reported issue.An alternate device was retrieved for use without delay.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On april 20, 2018, it was reported that the device was spontaneously decompressing at times and it was alarming.The customer returned an a.T.S.1200 tourniquet device, serial number (b)(4), for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet australia has not previously repaired/evaluated a.T.S.1200 tourniquet serial number (b)(4) as documented in the repair reports in livelink.Product review of the a.T.S.1200 tourniquet by zimmer biomet australia on april 20, 2018 revealed that the device was occluding on the second channel.The inflate valves were found to be turned around (photo taken).The valves are to be put in the correct position.With the valves in the correct position no occlusion errors were present.The decompression problem as reported was not observed.The battery also needed replaced.Repair of the a.T.S.1200 tourniquet was performed by zimmer biomet australia on april 20, 2018 which included replacement of the battery and placing the valves in the correct position.A.T.S.1200 tourniquet, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was non-verifiable since during the product review by zimmer biomet australia it was noted that the decompression problem as reported was not observed.However, it was found that the unit was occluding on the second channel.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by zimmer biomet australia it was noted that the decompression problem as reported was not observed.However, it was found that the unit was occluding on the second channel.It was found that the inflate valves had been installed backwards in the device.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: ATS 1200 W/HOSES, W/ENGLISH MANUAL
• Type of Device: TOURNIQUETS, PNEUMATIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7467907
• MDR Text Key: 106956495
• Report Number: 0001526350-2018-00364
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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: 60120010100
• Device Lot Number: 62689599
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1