BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERKELEY VACUUM CURETTAGE

    MDR report key: 9762842 · Received February 27, 2020

    Report

    Report Number
    9762842
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    October 18, 2019
    Report Date
    February 26, 2020
    Manufacturer
    BERKELEY MEDEVICES
    Product Code
    HHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNIT DEACTIVATED ON ITS OWN DURING USE ON POSTPARTUM PATIENT WITH HEMORRHAGE. MACHINE WAS TESTED TWICE BEFORE USE ON PATIENT AND WAS WORKING. DURING SUCTIONING OF BLOOD CLOTS FROM PATIENT, MACHINE STOPPED. STAFF ATTEMPTED TO TURN MACHINE OFF AND ON, EVEN UNPLUGGED AND REPLUGGED MULTIPLE TIMES IN DIFFERENT OUTLETS IN THE ROOM. MACHINE DID NOT TURN BACK ON. ANOTHER MACHINE WAS BROUGHT INTO THE ROOM. STAFF CONCERNS WITH NO TROUBLE SHOOTING ABILITIES THAN TWO FUNCTIONS - PLUG IN AND PULL KNOB AND FOR DEVICE TO STOP WORKING MID PROCEDURE WITH A HEMORRHAGING PATIENT. MALFUNCTIONED DEVICE WAS REVIEWED BY BIOMED AND NOTED UNIT HAD A TRIPPED CIRCUIT BREAKER. BIOMED WAS ABLE TO IDENTIFY AFTER AUTOMATIC SHUT DOWN DUE TO CLOTS, IT WOULD SHUT DOWN. BUT PROBLEM ASSOCIATED WITH MACHINE, NO ABILITY TO TURN BACK ON. IDENTIFIED MACHINE HAD TO BE DISASSEMBLED TO SWITCH BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224530 BERKELEY VACUUM CURETTAGE SYSTEM, ABORTION, VACUUM HHI BERKELEY MEDEVICES VC-2

    Patients

    Seq Age Sex Outcome Treatment
    1 11315 DA