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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. ATS 4000; TOURNIQUET, PNEUMATIC
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ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. ATS 4000; TOURNIQUET, PNEUMATIC Back to Search Results
Model Number ATS 4000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Skin Tears (2516)
Event Date 11/12/2020
Event Type  malfunction  
Event Description
During closure of procedure, surgeon noted a skin tear on lower incision site of left knee.After removal of tourniquet, bruising noted on left thigh at tourniquet site as well.30-inch tourniquet applied by nurse.Tourniquet inflated at a pressure of 225.Patient care manager aware of surgeon complaint in regards to tourniquets.Had biomed check tourniquet calibrations previously.Primary care manager states she will discuss the reprocessing process of the tourniquets with the sustainability company.
 
Event Description
During closure of procedure, surgeon noted a skin tear on lower incision site of left knee.After removal of tourniquet, bruising noted on left thigh at tourniquet site as well.30-inch tourniquet applied by nurse.Tourniquet inflated at a pressure of 225.Patient care manager aware of surgeon complaint in regards to tourniquets.Had biomed check tourniquet calibrations previously.Primary care manager states she will discuss the reprocessing process of the tourniquets with the sustainability company.
 
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Brand Name
ATS 4000
Type of Device
TOURNIQUET, PNEUMATIC
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
6481 franz warner pkwy.
whitsett NC 27377
MDR Report Key11002281
MDR Text Key221256095
Report Number11002281
Device Sequence Number1
Product Code DWL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberATS 4000
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2020
Event Location Hospital
Date Report to Manufacturer12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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