MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP. 30X4, 1BLA, 1PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Catalog Number	5921030135
Medical Device Problem Codes	Device Alarm System (1012); Decrease in Pressure (1490)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the tourniquet cuff kept alarming.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
Additional Manufacturer Narrative
Additional information added for d4, d10, h3.Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the tourniquet cuff kept alarming.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.

• Brand Name: DISP. 30X4, 1BLA, 1PRT, QUICK CONNECT
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10121043
• Report Number: 0001811755-2020-01388
• Device Sequence Number: 13991671
• Product Code: KCY
• UDI-Device Identifier: 37613154599418
• UDI-Public: 37613154599418
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: Health Professional
• Device Catalogue Number: 5921030135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1