BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEDURAL TRANSPORT STRETCHER

    MDR report key: 3812562 · Received April 17, 2014

    Report

    Report Number
    3006697241-2014-00361
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICAL SUPPORT REP PERFORMED TROUBLESHOOTING OVER THE PHONE WITH THE ACCOUNT, AND RECOMMENDED THE REPLACEMENT OF A BRAKE LINK. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON ITS BEDS. HILL-ROM TECHNICAL SUPPORT 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 WERE NOT HOLDING. THE BED WAS LOCATED IN THE BED SHOP AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236017 PROCEDURAL TRANSPORT STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1