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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC
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STRYKER INSTRUMENTS-KALAMAZOO DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC Back to Search Results
Catalog Number 5921034135
Medical Device Problem Code Decrease in Pressure (1490)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.  product return status: 2 devices were received.Event confirmation status: 2 reported events were confirmed; the cause traced to component failure.Evaluation results: 2 devices were found to be affected by a stress problem.Additional information: 2 devices were labeled for single-use.2 devices were not reprocessed and reused.
 
Event or Problem Description
This report summarizes 2 malfunction events in which the device decreased in pressure.2 events had patient involvement; no patient impact.
 
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Brand Name
DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT
Common Device Name
TOURNIQUET, PNEUMATIC
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8545837
Report Number0001811755-2019-01345
Device Sequence Number14061214
Product Code KCY
UDI-Device Identifier37613154599456
UDI-Public37613154599456
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized2
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/24/2019
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 Catalogue Number5921034135
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/01/2019
Initial Report FDA Received Date04/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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