BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIED HELATHCARE PRODUCTS INC.

    MDR report key: 18250824 · Received December 1, 2023

    Report

    Report Number
    1924066-2023-00004
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    September 1, 2023
    Report Date
    July 24, 2024
    Manufacturer
    ALLIED HEALTHCARE PRODCUTS INC
    Product Code
    BTL
    UDI-DI
    00026072000267
    PMA / PMN Number
    K090356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED THE UNIT AND IT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY 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 (B)(6) 2023, WHICH WAS WHEN ALLIED MEDICAL LLC WAS CREATED. PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS.

    Description of Event or Problem · 0

    THE PATIENT WAS CONNECTED TO THE EPV200 WENT INTO DESATURATION AND STARTED HAVING PRBLEMS WITH BREATHING. THE STAFF HAD TO CALL A RAPID RESPONSE TEAM AND A MEDICAL EMERGENCY CODE. DURING THIS INCIDENT IT DID NOT MAKE A SINGLE SOUND.

    Description of Event or Problem · 0

    THE PATIENT WAS CONNECTED TO THE EPV200 WENT INTO DESATURATION AND STARTED HAVING PROBLEMS WITH BREATHING. THE STAFF HAS TO CALL A RAPID RESPONSE TEAM AND A MEDICAL EMERGENCY CODE. DURING THIS INCIDENT IT DID NOT MAKE A SINGLE SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504119 ALLIED HELATHCARE PRODUCTS INC. EPV200 BTL ALLIED HEALTHCARE PRODCUTS INC EPV200 NO 00026072000267

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention