BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-1 COT - BASE HIGH LOAD 28

    MDR report key: 3201945 · Received July 2, 2013

    Report

    Report Number
    0001831750-2013-05959
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE FOR THE DROP IS UNKNOWN AS THE EVALUATION OF THE COT IDENTIFIED THAT THE UNIT WAS FULLY FUNCTIONAL, WITH NO DEFECTS OR MALFUNCTIONS IDENTIFIED. BASED ON A REVIEW OF PREVIOUS SIMILAR COMPLAINTS, THERE IS A POTENTIAL THAT THE BASE OF THE UNIT MAY NOT HAVE BEEN VERIFIED TO BE LOCKED. THE MANUAL ADVISES THAT THE GRIP ON THE COT SHOULD NOT BE RELAXED UNTIL THE COT IS ENSURED TO BE IN THE LOCKED POSITION. IF THE COT IS NOT LOCKED IN POSITION, A DROP COULD OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT DROPPED AT THE HEAD END FROM THE HIGHEST LEVEL TO THE LOWEST. 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 COT DROPPED AT THE HEAD END FROM THE HIGHEST LEVEL TO THE LOWEST. 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
    302873 M-1 COT - BASE HIGH LOAD 28 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1