BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX-PRO R-3 AMBULANCE COT

    MDR report key: 4441725 · Received January 22, 2015

    Report

    Report Number
    0001831750-2015-00031
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    December 14, 2014
    Report Date
    January 5, 2015
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING THE TRANSPORT OF THE PATIENT TO THE AMBULANCE, THE CREW WENT OVER A WATER DRAIN AND THE GRATE COVER BROKE, CAUSING THE FRONT LEFT CASTER OF THE COT TO GET CAUGHT AND BREAK OFF. THIS THEN CAUSED THE COT TO TIP OVER, AND THE PATIENT REPORTEDLY SUSTAINED A CONTUSION TO THE LEFT EYEBROW WHICH REQUIRED NO ADDITIONAL MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN TRANSPORTING AN OBESE PATIENT TO THE AMBULANCE THEY WENT OVER A WATER DRAIN AND THE GRATE COVER BROKE, CAUSING THE FRONT LEFT WHEEL OF THE STRETCHER TO GET CAUGHT AND THE COT WHEEL BROKE AS WELL. THE COT TIPPED OVER, AND THE PATIENT REPORTEDLY SUSTAINED A CONTUSION TO THE LEFT EYEBROW. NO MEDICAL INTERVENTION WAS REQUIRED. IT WAS FURTHER REPORTED ONE OF THE EMTS SUSTAINED AN UNSPECIFIED INJURY AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN TRANSPORTING AN OBESE PATIENT TO THE AMBULANCE THEY WENT OVER A WATER DRAIN AND THE GRATE COVER BROKE, CAUSING THE FRONT LEFT WHEEL OF THE STRETCHER TO GET CAUGHT AND THE COT WHEEL BROKE AS WELL. THE COT TIPPED OVER, AND THE PATIENT REPORTEDLY SUSTAINED A CONTUSION TO THE LEFT EYEBROW. NO MEDICAL INTERVENTION WAS REQUIRED. IT WAS FURTHER REPORTED ONE OF THE EMTS SUSTAINED AN UNSPECIFIED INJURY AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52435 MX-PRO R-3 AMBULANCE COT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1