BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2 BED

    MDR report key: 3810411 · Received April 11, 2014

    Report

    Report Number
    3006697241-2014-00334
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE COMMUNICATION CABLE WAS NOT INSTALLED ON THE WALL CORRECTLY AND THE ACCOUNT WAS USING THE WRONG COMMUNICATION CABLE. PER THE HILL-ROM SERVICE MANUAL THE ADVANTA 2 SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. THIS WILL HELP MAKE SURE OF A LONG, OPERATIVE LIFE FOR THE ADVANTA 2 BED. THE PREVENTATIVE MAINTENANCE WILL HELP TO REDUCE DOWNTIME DUE TO EXCESSIVE WEAR FAILURES. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. SIDECOM COMMUNICATION SYSTEM: INSPECT AND TEST THE COMMUNICATION JUNCTION BOX. MAKE SURE THE SIDECOM COMMUNICATION SYSTEM FEATURES OPERATE CORRECTLY. INSPECT THE COMMUNICATION CABLE, INCLUDING THE MALE AND FEMALE PINS IN THE PLUG. REPLACE AS NECESSARY. 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 HILL-ROM TECHNICIAN INSTALLED THE COMMUNICATION CABLE CORRECTLY AND INSERVICED THE ACCOUNT ON PROPER CORD USAGE. 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 BED WAS COMMUNICATING WITH THE HEAD WALL INTERMITTENTLY. THE BED WAS LOCATED AT THE ACCOUNT ON THE 4TH FLOOR. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221649 ADVANTA 2 BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILLROM DE MEXICO S DE RL DE CV 1190

    Patients

    Seq Age Sex Outcome Treatment
    1