BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYP0 PAD

    MDR report key: 3070860 · Received April 22, 2013

    Report

    Report Number
    0001831750-2013-03610
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INSPECTING THE DEVICE, SPEAKING WITH A SUBJECT MATTER EXPERT, AND A REVIEW OF PREVIOUS SIMILAR COMPLAINTS, IT WAS IDENTIFIED THAT A LIKELY LEVEL CAUSE AS TO WHY THE BLANKET HAD BEEN LEAKING IS FROM AN EXTERNAL SHARP OBJECT PUNCTURING THE BLANKET ALLOWING IT TO LEAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HYPOTHERMIA PAD WAS LEAKING FLUID. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HYPOTHERMIA PAD WAS LEAKING FLUID. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171546 HYP0 PAD SYSTEM, THERMAL REGULATING DWJ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1