BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIED HEALTHCARE PRODUCTS INC.

    MDR report key: 18167167 · Received November 19, 2023

    Report

    Report Number
    1924066-2023-00003
    Event Type
    Malfunction
    Date Received
    November 19, 2023
    Date of Event
    January 10, 2023
    Report Date
    July 23, 2024
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS INC.
    Product Code
    BTL
    UDI-DI
    000267200014
    PMA / PMN Number
    K132021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QAULITY UPDATES ONLY** SEVERAL UPDATES HAVE BEEN MADE TO THIS REPORT. THE FULL UDI HAS BEEN ENTERED, ALONG WITH THE 5 10(K). THE INFORMATION ENTERED IN THIS REPORT AND THAT OF THE GUDID THAT DID NOT MATCH ARE THE BRAND NAME AND THE MANUFACTURER NAME. THE REASONING BEHIND THIS DIFFERENCE IS THAT WE WERE CONSIDERED ALLIED HEALTHCARE PRODUCTS INC. WHEN THE SUSPECT MEDICAL DEVICES WERE MANUFACTURED AS WELL AS WHEN THE MALFUNCTION OCCURRED. THE MEDWATCH WAS SUBMITTED AFTER WE BECAME ALLIED MEDICAL LLC. THE REASON BEHIND THIS IS ALLIED HEALTHCARE PRODUCTS INC. DECLARED BANKRUPTCY AND ITS ASSETS WERE SOLD ON JULY 13, 2023, WHICH WAS WHEN ALLIED MEDICAL LLC WAS CREATED. PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS.

    Additional Manufacturer Narrative · 0

    THE UNIT WAS TESTED AS RECEIVED AND WAS OUT OF CALIBRATION. THERE WERE NO LEAKS DETECTED AND THE VENT WAS VERIFYED TO BE CHARGING AND THE FAN RUNNING.

    Description of Event or Problem · 0

    PER THE CREW, THIS VENTILATOR SUFFERED A FAILURE DURING TRANSPORT. THEY WERE USING CPAP MODE AND THE UNITL ALARMED AND STOPPED DELIVERING OXYGEN. IT WENT FROM 3/4 BATTERY TO DEAD.

    Description of Event or Problem · 0

    PER THE CREW, THIS VENTILATOR SUFFERED A FAILURE DURING TRANSPORT. THEY WERE USING CPAP MODE AND THE UNIT ALARMED AND STOPPED DELIVERING OXYGEN. IT WENT FROM 3/4 BATTERY TO DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916743 ALLIED HEALTHCARE PRODUCTS INC. AHP300 BTL ALLIED HEALTHCARE PRODUCTS INC. AHP300 NO 000267200014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown