BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PRO AMBULANCE COT

    MDR report key: 2981216 · Received February 27, 2013

    Report

    Report Number
    0001831750-2013-01563
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INVESTIGATION, THE ALLEGED COT LOWERING (DRIFTING / DROPPING) EVENT IS UNKNOWN AS THERE WAS NO SPECIFIC MALFUNCTION FOUND WITH THE DEVICE. THE TECHNICIANS EVALUATION FOUND THE PRODUCT TO BE OPERATING TO SPECIFICATIONS WITH NO IDENTIFIED DEFECTS. FURTHER REVIEW FROM THE TECHNICIAN, A REVIEW OF PREVIOUS SIMILAR COMPLAINTS, AND A REVIEW OF THE MANUAL IDENTIFIED THAT A POSSIBLE CAUSE FOR THE UNEXPECTED COT LOWERING MAY HAVE BEEN DUE TO OPERATOR ERROR FROM UNINTENTIONALLY ENGAGING THE MANUAL RELEASE. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY VERIFYING THE COT MET SPECIFICATIONS AND REVIEWING THE POTENTIAL OF THE EVENT BEING CAUSED OR CONTRIBUTED FROM OPERATOR ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT SUDDENLY DROPPED DOWN VERY QUICKLY WHEN PRESSING THE MINUS BUTTON. HOWEVER, THE COT RAISED NORMALLY AND EVERYTHING WAS WORKING NORMAL AFTER. FURTHERMORE, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT SUDDENLY DROPPED DOWN VERY QUICKLY WHEN PRESSING THE MINUS BUTTON. HOWEVER, THE COT RAISED NORMALLY AND EVERYTHING WAS WORKING NORMAL AFTER. FURTHERMORE, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83780 POWER PRO AMBULANCE COT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1