BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD STRETCHER

    MDR report key: 4092608 · Received September 8, 2014

    Report

    Report Number
    3006697241-2014-00652
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE SIDE RAIL LATCH BOLT AND NUT WERE MISSING. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE SIDE RAIL LATCH BOLT AND NUT TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE SIDE RAIL WOULD NOT LATCH. THE BED WAS LOCATED IN AN OUTSIDE WORK AREA AT THE ACCOUNT. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYS AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547542 STD STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8005

    Patients

    Seq Age Sex Outcome Treatment
    1