MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REUSE. 18X4, 1BLA, 1PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Catalog Number	5922218135
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported that during a procedure, a tourniquet cuff was causing the low pressure alarm to sound on the tourniquet device; when the tourniquet cuff was switched out, the device 's alarm ceased.There was no report of a malfunction with the tourniquet device.There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required.The procedure was completed successfully with a back up tourniquet cuff.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
The user reported that during a procedure, a tourniquet cuff was causing the low pressure alarm to sound on the tourniquet device; when the tourniquet cuff was switched out, the device 's alarm ceased.There was no report of a malfunction with the tourniquet device.There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required.The procedure was completed successfully with a back up tourniquet cuff.

• Brand Name: REUSE. 18X4, 1BLA, 1PRT, QUICK CONNECT
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• MDR Report Key: 8016761
• Report Number: 0001811755-2018-02226
• Device Sequence Number: 1030037
• Product Code: KCY
• UDI-Device Identifier: 07613154600175
• UDI-Public: 07613154600175
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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 Catalogue Number: 5922218135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1