BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER PRO AMBULANCE COT - OBS

    MDR report key: 3821328 · Received May 20, 2014

    Report

    Report Number
    0001831750-2014-02992
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 23, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED BY A STRYKER FIELD SERVICE REPRESENTATIVE. IT WAS ALLEGED THAT THE COT MISSED THE SAFETY BAR AND DROPPED OUT OF THE AMBULANCE WITH A PATIENT. IT WAS FURTHER REPORTED THAT THE AMBULANCE WAS PARKED ON AN INCLINE (LEFT TO RIGHT) WHICH CAUSED THE COT AND THE PATIENT TO TIP ONTO ONE LOAD WHEEL HIGH ENOUGH FOR THE SAFETY BAR TO MISS THE HOOK. THE PATIENT RECEIVED SCRAPES THAT REQUIRED MEDICAL INTERVENTION FROM THE EVENT. IN ADDITION, IT WAS REPORTED THAT THERE WAS ONLY ONE USER AT THE FOOT END DURING THE UNLOADING PROCEDURE. UPON EVALUATION, THE FIELD TECHNICIAN WAS UNABLE TO DUPLICATE THE ALLEGED EVENT AND FOUND NO DEFECTS WITH THE DEVICE. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY INSTRUCTING THE CUSTOMER ON HOW TO PROPERLY UNLOAD THE COT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY ALLEGEDLY DROPPED A PATIENT BY MISSING A SAFETY HOOK. THE CUSTOMER REPORTED THAT THE AMBULANCE WAS PARKED ON A GRADE AT THE HOSPITAL WITH A PATIENT ON THE COT AND AS THEY CAME OUT OF THE BACK OF THE TRUCK, THE WHEELS SWIVELED AND THEY MISSED THE HOOK. 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 BY THE CUSTOMER THAT THEY ALLEGEDLY DROPPED A PATIENT BY MISSING A SAFETY HOOK. THE CUSTOMER REPORTED THAT THE AMBULANCE WAS PARKED ON A GRADE AT THE HOSPITAL WITH A PATIENT ON THE COT AND AS THEY CAME OUT OF THE BACK OF THE TRUCK, THE WHEELS SWIVELED AND THEY MISSED THE HOOK. THE PATIENT RECEIVED SCRAPES THAT REQUIRED MEDICAL INTERVENTION FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300171 POWER PRO AMBULANCE COT - OBS STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1