BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA2 RENTAL BED

    MDR report key: 16375287 · Received February 14, 2023

    Report

    Report Number
    3006697241-2023-00010
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 16, 2023
    Report Date
    February 14, 2023
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HILLROM TECHNICIAN FOUND THE FRAME NEEDED TO BE CALIBRATE. PER THE HILLROM SERVICE MANUAL THE ADVANTA¿ 2 SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. TEST EACH OF THE BUTTONS TO CHECK THAT THEY ACTIVATE THE CORRECT FUNCTION AND THAT THEY DO NOT WORK INTERMITTENTLY BY PRESSING EACH BUTTON FOR SEVERAL SECONDS. EACH MOVEMENT MUST BE CONTINUOUS. REPLACE THE PENDANT IF NECESSARY. A SEARCH OF THE HILLROM MAINTENANCE RECORDS SHOWED HILLROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN DECEMBER 2022. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN CALIBRATED THE BED FRAME TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE HEAD OF BED WAS MOVING ON ITS OWN. THE BED WAS LOCATED 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
    1516972 ADVANTA2 RENTAL BED BED, MANUAL FNJ HILL-ROM MEXICO P1190ARENT01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown