BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIED HEALTHCARE PRODUCTS INC.

    MDR report key: 18024143 · Received October 27, 2023

    Report

    Report Number
    1924066-2021-00001
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    September 22, 2021
    Report Date
    July 29, 2024
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS INC
    Product Code
    BTL
    PMA / PMN Number
    K090356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Description of Event or Problem · 0

    PRESSURE SENSOR VALVE POPPED APART UNDER PRESSURE MAKING A LOUD NOISE CAUSING A LEAKAGE AND LOW SOURCE GAS ALARM

    Description of Event or Problem · 0

    PRESSURE SENSOR VALVE POPPED APART UNDER PRESSURE MAKING A LOUD NOISE CAUSING A LEAKAGE AND LOW SOURCEGAS ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789690 ALLIED HEALTHCARE PRODUCTS INC. EPV200 BTL ALLIED HEALTHCARE PRODUCTS INC EPV200 NO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown