BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NARROW TREATMENT RECLINER

    MDR report key: 3775150 · Received April 28, 2014

    Report

    Report Number
    0001831750-2014-02935
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE FRONT LEFT CASTER WAS BROKEN OFF. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. UPON FURTHER INVESTIGATION IT WAS CONCLUDED THAT HE UNIT WAS AT THE RECEIVING DOCK AT THE HOSPITAL PRIOR TO THE REPAIR AND NO PATIENTS WOULD HAVE ACCESS TO THE CHAIR. THE UNIT WAS NOT PLACED INTO SERVICE PRIOR TO THE REPAIR WHEN IT ARRIVED AT THE HOSPITAL. THE ISSUE REPORTED IS NOT LIKELY TO CONTRIBUTE TO SERIOUS INJURY OR DEATH AS THIS SERVICE REPORT DOES NOT REQUIRE AN MDR BECAUSE THE FAILURE WAS NOTICED OUT OF BOX AND NOT PUT INTO SERVICE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FRONT LEFT CASTER WAS BROKEN OFF. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FRONT LEFT CASTER WAS BROKEN OFF. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254736 NARROW TREATMENT RECLINER CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1