BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEDURAL STRETCHER

    MDR report key: 3952457 · Received May 14, 2014

    Report

    Report Number
    3006697241-2014-00448
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT DETERMINED THE SIDE RAIL END TUBE WAS BROKEN. 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 THEIR BEDS. TECHNICAL SUPPORT PROVIDED THE PART NUMBER OF THE SIDE RAIL END TUBE. THEY INSTRUCTED THE DISTRIBUTOR TO REPLACE THE END TUBE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A DISTRIBUTOR STATING THE SIDE RAIL WOULD NOT LATCH. THE BED WAS LOCATED IN THE SHOP. 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
    288283 PROCEDURAL STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1