BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 5097018 · Received September 23, 2015

    Report

    Report Number
    1824206-2015-00911
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    PMA / PMN Number
    PK962942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE HOT SPADE WAS BROKEN OFF AND THE GROUND AND NEUTRAL SPADES WERE BENT. PER THE HILL-ROM SERVICE MANUAL THE TOTALCARE BED SYSTEM REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM A SEMI-ANNUAL PREVENTATIVE MAINTENANCE. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. EXAMINE THE POWER CORDS AND PLUGS FOR CUTS, NICKS, BREAKS, FRAYS AND FOR CORRECT GROUNDING. 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. THE TECHNICIAN REPLACED THE POWER CORD 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 THE ACCOUNT STATING THE BEDS POWER CORD WAS MELTED AND CHARRED. THE BED WAS LOCATED ON THE SECOND FLOOR 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
    628505 TOTALCARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM BATESVILLE P1900AB3763

    Patients

    Seq Age Sex Outcome Treatment
    1