BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM CRITICAL CARE BED

    MDR report key: 3130487 · Received May 24, 2013

    Report

    Report Number
    0001831750-2013-04767
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY REPLACING THE CONNECTOR BOX AND ASSOCIATED HARDWARE/LABEL PROVIDED FROM CUSTOMER SUPPLY.

    Additional Manufacturer Narrative · 1

    UNIT TO BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE AUXILIARY OUTLET WAS DAMAGED WITH EXPOSED ELECTRICAL WIRES. 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 AUXILIARY OUTLET WAS DAMAGED WITH EXPOSED ELECTRICAL WIRES. 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
    231107 ZOOM CRITICAL CARE BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1