BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER FRAME

    MDR report key: 4092396 · Received September 5, 2014

    Report

    Report Number
    3006697241-2014-00650
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ORDERED ALL BRAKE CASTERS TO REPAIR THE BED. HILL-ROM CONTACTED THE CUSTOMER TWO ADDITIONAL TIMES TRYING TO OBTAIN THE RESOLUTION FOR THIS ALLEGED ISSUE. NO RESPONSE HAS BEEN RECEIVED FROM THE ACCOUNT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BRAKES WOULD NOT LOCK INTO PLACE ONCE THE BRAKES WERE SET. THE CUSTOMER STATED THE CASTERS WOULD SWIVEL AND ROLL WHEN BEING PUSHED (BRAKES NOT HOLDING). THE BED WAS LOCATED IN THE REPAIR SHOP. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545936 TRANSTAR STRETCHER FRAME WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1