BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISION BLOWER KIT

    MDR report key: 17404282 · Received July 27, 2023

    Report

    Report Number
    1824206-2023-00820
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 20, 2023
    Report Date
    July 27, 2023
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    ICQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HILLROM TECHNICIAN FOUND THE¿POWER CORD NEEDED TO BE REPLACED. THE ENVISION LOW AIRLOSS THERAPY SURFACE HELPS PREVENT AND TREAT STAGE III AND IV PRESSURE ULCERS IN PATIENTS WHO WEIGH BETWEEN 70LB AND 400LB (32KG AND 181KG) AND ARE BETWEEN 4¿ 11¿ AND 6¿4¿ (150CM TO 193CM) IN HEIGHT. PER THE HILLROM SERVICE MANUAL, EXAMINE THE POWER CORD AND ITS PLUG FOR DAMAGE. EXAMINE THE LENGTH OF THE POWER CORD FOR CUTS AND ABRASIONS. PLUG THE POWER CORD INTO A CALIBRATED SAFETY ANALYZER AND ATTACH THE ANALYZER TO THE EXPOSED METAL CHASSIS GROUND TEST POINT TO MAKE SURE THE GROUND RESISTANCE IS NO MORE THAN 200 MILLIOHMS. PLUG THE POWER CORD INTO A CALIBRATED SAFETY ANALYZER AND MAKE SURE THE LEAKAGE CURRENT IS NO MORE THAN 300 MICROAMPS IN NORMAL CONDITION (NC). REPLACE AS NECESSARY. 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

    IT WAS REPORTED THAT POWER CORD WAS DAMAGED WITH COPPER WIRE EXPOSED. 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
    755429 ENVISION BLOWER KIT BED, FLOTATION THERAPY, POWERED ICQ HILL-ROM BATESVILLE P136026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown