BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEDURLA STRETCHER

    MDR report key: 3904989 · Received June 9, 2014

    Report

    Report Number
    3006697241-2014-00498
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH DID NOT KNOW THE CAUSE OF THE BRAKE CASTER NOT HOLDING BUT WAS LIKELY DUE TO NORMAL WEAR AND TEAR. 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 BRAKE PAD WAS ADJUSTED BY THE TECH TO RESOLVE THE ISSUE. THE TECH THOROUGHLY TESTED THE BED EXIT SYSTEM AND IT FUNCTIONED AS DESIGNED. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECH REPORTED THAT THE BRAKE CASTERS DID NOT BRAKE PROPERLY (IT WAS ROLLING WHILE IN BRAKE MODE). THE BED WAS LOCATED AT THE FACILITY. THERE WAS NO PT/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
    336395 PROCEDURLA STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1