BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIME BIG WHEEL STRETCHER

    MDR report key: 3843440 · Received June 2, 2014

    Report

    Report Number
    0001831750-2014-03034
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 7, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT COULD NOT BE LOCATED FOR EVALUATION. THE DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO APPLY THE BRAKES ON A BIG WHEEL STRETCHER, A NURSE ALLEGEDLY INJURED THEIR KNEE DUE TO THE BRAKES BEING DIFFICULT TO ENGAGE. A STRYKER QUALITY ASSURANCE ENGINEER, CONTACTED THE DIRECTOR OF BIOMED SERVICES, REGARDING THE ALLEGED EVENT. THE DIRECTOR OF BIOMED SERVICES CONFIRMED THAT THE NURSE MAY HAVE INJURED THEMSELVES DUE TO THE DISTANCE THEY WERE STANDING AWAY FROM THE PEDAL SYSTEM. THE DIRECTOR OF BIOMED SERVICES STATED THAT NURSE IS A SHORTER PERSON AND WAS STANDING TOO FAR TO THE SIDE OF THE PEDAL, INSTEAD OF DIRECTLY OVER THE PEDAL, AS THEY ARE INSTRUCTED TO DO BY THE ACCOUNT MANAGEMENT. WHILE OPERATING THE PEDAL, THE NURSE TWISTED THEIR KNEE, REQUIRING SURGERY. IT WAS IDENTIFIED BY THE DIRECTOR OF BIOMED SERVICES THAT USER ERROR WAS THE LIKELY CAUSE OF THE INJURY AND THE NURSE HAS BEEN PROPERLY INSTRUCTED ON HOW TO OPERATE THE STRETCHER SINCE THE ALLEGED INCIDENT OCCURRED. A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED BY THE STRYKER FIELD SERVICE REPRESENTATIVE WHO CONFIRMED THAT THE SPECIFIC UNIT THAT WAS INVOLVED IN THE ALLEGED INJURY COULD NOT BE LOCATED BECAUSE THE CUSTOMER WAS UNABLE TO PROVIDE A SPECIFIC SERIAL NUMBER. THE STRYKER QUALITY ASSURANCE ENGINEER, CONFIRMED WITH THE CUSTOMER THEY WERE NOT ALLEGING ANY MALFUNCTION WITH THE UNIT AND THAT ALL OF THE CUSTOMER'S BIG WHEEL STRETCHERS ARE IN SERVICE AND OPERATING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THERE WAS AN EVENT INVOLVING A BIG WHEEL STRETCHER AND AN X-RAY TECHNICIAN THAT RESULTED IN A LEG INJURY REQUIRING SURGERY. IT HAS BEEN REPORTED THAT THE CUSTOMER WILL NOT RELEASE ANY FURTHER INFORMATION REGARDING THE INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THERE WAS AN EVENT INVOLVING A BIG WHEEL STRETCHER AND AN X-RAY TECHNICIAN THAT RESULTED IN A LEG INJURY REQUIRING SURGERY. IT HAS BEEN REPORTED THAT THE CUSTOMER WILL NOT RELEASE ANY FURTHER INFORMATION REGARDING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321845 PRIME BIG WHEEL STRETCHER STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1