BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNTROLR, RNT CLRT 120V US

    MDR report key: 16004661 · Received December 19, 2022

    Report

    Report Number
    1824206-2022-00534
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 19, 2022
    Report Date
    December 19, 2022
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HILLROM TECHNICIAN FOUND THE POWER CORD WAS RUN OVER AND NEEDED TO BE REPLACED. THE COMPELLA¿ BARIATRIC BED SYSTEM IS INTENDED TO PROVIDE PATIENT SUPPORT IN HEALTH CARE ENVIRONMENTS AND MAY BE USED IN A VARIETY OF SETTINGS INCLUDING, BUT NOT LIMITED TO, ACUTE CARE, INCLUDING CRITICAL CARE, STEP DOWN/PROGRESSIVE CARE, MEDICAL/SURGICAL, HIGH ACUITY SUB-ACUTE CARE, POST ANESTHESIA CARE UNIT (PACU), AND SECTIONS OF THE EMERGENCY DEPARTMENT (ED). IT IS CAPABLE OF BEING USED WITH A BROAD PATIENT POPULATION AS DETERMINED APPROPRIATE BY THE CAREGIVER OR INSTITUTION AND IS INTENDED FOR PATIENTS BETWEEN 113 KG AND 454 KG (250 LB AND 1000 LB). A SEARCH OF THE HILLROM MAINTENANCE RECORDS SHOWED HILLROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN OCTOBER 2022. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE POWER CORD 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 POWER CORD SPARKED. 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
    2201287 CNTROLR, RNT CLRT 120V US BARIATRIC BED OSI HILL-ROM BATESVILLE P7810ARC3A0ENG1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown