BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-1 COT - BASE HIGH LOAD 28

    MDR report key: 2925626 · Received January 22, 2013

    Report

    Report Number
    0001831750-2013-00273
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    October 20, 2012
    Report Date
    December 18, 2012
    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

    DURING THE COURSE OF THE INVESTIGATION IT WAS NOTED THAT THE RETAINING POST WAS WORN. THE RETAINING POST (PN: (B)(4)) ON THE UNIT WAS REPLACED HOWEVER THIS WAS DETERMINED TO NOT HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BASED ON THE EVENT DESCRIPTION, THE FOOT END LEGS DID NOT HOLD AND COLLAPSED WHEN THE COT WAS UNLOADED FROM THE AMBULANCE. THE UNIT WAS DESCRIBED TO BE TRANSPORTING AN INCUBATOR AT THE TIME THE EVENT OCCURRED. BASED ON A REVIEW OF PREVIOUS SIMILAR INVESTIGATIONS, A LIKELY CAUSE AS TO WHY THE COT COLLAPSED IS DUE TO THE LEGS NOT BEING VERIFIED TO BE LOCKED. THE MANUAL STATES TO ENSURE THAT THE LEGS ARE LOCKED DURING THE UNLOADING PROCESS. AN ADDITIONAL CONTRIBUTING FACTOR TO THE COT DROP EVENT IS DUE TO THE UNIT BEING USED TO TRANSPORT AN INCUBATOR. THE M1 COT IS NOT DESIGNED TO BE USED TO TRANSPORT AN INCUBATOR. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO THE DROP EVENT MAY BE DUE TO THE COT BEING USED PAST ITS LIFE EXPECTANCY.

    Description of Event or Problem · 1

    OUR CUSTOMER USED THE M1 COT WITH A TRANSPORT INCUBATOR (DRAGERTI500). DURING UNLOADING FROM THE AMBULANCE THE DEVICE COMBINATION OVERTURNED, BECAUSE THE COT COLLAPSED AT THE FOOT END. THE INCUBATOR WAS TURNED UP AND THE TRANSPORTATION WAS CONTINUED BY HAND.

    Description of Event or Problem · 1

    OUR CUSTOMER USED THE M1 COT WITH A TRANSPORT INCUBATOR (DRÄGERTI500). DURING UNLOADING FROM THE AMBULANCE THE DEVICE COMBINATION OVERTURNED, BECAUSE THE COT COLLAPSED AT THE FOOT END. THE INCUBATOR WAS TURNED UP AND THE TRANSPORTATION WAS CONTINUED BY HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30197 M-1 COT - BASE HIGH LOAD 28 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 6100

    Patients

    Seq Age Sex Outcome Treatment
    1