BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSATE BLOWER ASSEMBLY

    MDR report key: 18370311 · Received December 20, 2023

    Report

    Report Number
    3002693132-2023-70002
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    September 19, 2023
    Report Date
    December 19, 2023
    Manufacturer
    AGILITI HEALTH - ELLIS
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    AN EMPLOYEE OF PIEDMONT OR PATIENT OR PATIENT FAMILY MEMBER IN SOME WAY PULLED THE RECEPTACLE THAT IS ATTACHED TO THE BLOWER BY TWO RIVETS. THIS RECEPTACLE WAS PULLED OUT AND PULLED AWAY FROM THE THREE WIRES CONNECTED INTO THE BACK OF IT. THE INDIVIDUAL WHO DID THIS THEN DRAPED THE BROKEN END OF THE CORD OVER THE HEAD OF THE HEAD OF THE BED AND LEFT IT THERE. AT SOME POINT LATER A NURSE CAME AS THE MATTRESS WAS NOT INFLATING BECAUSE THE CORD AND RECEPTACLES HAD BEEN PULLED OUT OF THE BLOWER. WHEN THE NURSE GRABBED THE CORD BECAUSE IT WAS STILL PLUGGED IN TO THE WALL IT SPARKED AND THERE WAS A POP. WHILE NO PATIENT INJURY OCCURRED, THE POTENTIAL FOR SERIOUS INJURY NECESSITATES REPORTING THIS INCIDENT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170173 PULSATE BLOWER ASSEMBLY MATTRESS CONTROL UNIT IOQ AGILITI HEALTH - ELLIS 31561

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown