MAUDE Adverse Event Report: . A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR (PERSONALIZED PRESSURE®); TOURNIQUET, PNEUMATIC

Model Number N/A

Device Problems Calibration Problem (2890); Output Problem (3005); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

This complaint has been recorded under (b)(4).Once completed a supplemental/final report will be submitted.

Event Description

It was reported that prior to surgery the device had calibration issues.Once in surgery the device was noted to have different readings and pressure was believed to be too high.No harm or delay were reported along with this event.No other adverse events were reported along with this event.

Event Description

No additional information is available.

Manufacturer Narrative

This complaint has been submitted under (b)(4).Review of the most recent repair record identified no related findings/repairs to the reported event.Device was assessed and met all specifications.Device was returned to the customer.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR (PERSONALIZED PRESSURE®)
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): .; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14138029
• MDR Text Key: 289467263
• Report Number: 0001526350-2022-00360
• Device Sequence Number: 1
• Product Code: KCY
• UDI-Device Identifier: 00889024376731
• UDI-Public: (01)00889024376731(11)201107(10)64928407
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: 60400010100
• Device Lot Number: 64928407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1