BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC VRI AHA VENTILATOR WITH REGULATOR AND CIRC

    MDR report key: 17492530 · Received August 9, 2023

    Report

    Report Number
    3012307300-2023-07954
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Report Date
    June 21, 2024
    Manufacturer
    ST PAUL
    Product Code
    BZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: ADDITIONAL INFORMATION IS PROVIDED IN H.2., H.3., AND H.6. FUNCTIONAL TESTING DID NOT CONFIRM THE CUSTOMER'S COMPLAINT. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DHR REVIEW WAS NOT PERFORMED. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FOR ALL ENQUIRIES OR FOLLOW-UP QUESTIONS RELATED TO THE RECORD, DO NOT USE [email protected] LOCATED IN SECTIONS G.1., PLEASE DIRECT THOSE TO THE FOLLOWING: [email protected]. D.4. FULL UDI NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    OTHER TEXT: B3: DATE OF EVENT, D4: UDI SECTION UNKNOWN, AND G5: 510K ARE UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WILL NOT CYCLE AND NEEDS PREVENTIVE MAINTENANCE. PATIENT INVOLVEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684413 PNEUPAC VRI AHA VENTILATOR WITH REGULATOR AND CIRC VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BZL ST PAUL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown