MAUDE Adverse Event Report: STRYKER CORPORATION COLOR CUFF; TOURNIQUET, PNEUMATIC

Model Number	5921218235
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Tourniquet would not inflate.Changed machine and tubing.Surgeon used a hemaclear tourniquet instead.Used a second stryker tourniquet with same lot number, after testing it, worked fine for second patient.

• Brand Name: COLOR CUFF
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 8568660
• Report Number: 8568660
• Device Sequence Number: 1836742
• Product Code: KCY
• UDI-Device Identifier: 07613154599752
• UDI-Public: (01)07613154599752(17)201011(10)60120829
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019
• Report Date (Section F): 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 5921218235
• Device Catalogue Number: 5921218235
• Device Lot Number: 60120829
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/11/2019