BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTOVENT CPAPOS

    MDR report key: 4008503 · Received May 14, 2014

    Report

    Report Number
    3004168154-2014-00001
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    March 21, 2014
    Report Date
    May 13, 2014
    Manufacturer
    EMERGENT RESPIRATORY LLC
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, EMERGENT RESPIRATOR, LLC RECEIVED THE MAUDE EVENT REPORT (VOL #(B)(4)). THE SERIAL NUMBER OF THE CPAP UNITS WAS NOT REPORTED ON THE MAUDE EVENT REPORT NOR WAS THE DETAILS OF HOW THE UNIT FAILED. IT WAS REPORTED THAT "NO ADVERSE EFFECT TO PT". EMERGENT RESPIRATORY, LLC INITIALLY REACHED OUT TO(B)(6) 2014 WE RECEIVED A RESPONSE WITH THE SERIAL NUMBER OF THE CPAP UNIT. INFO ABOUT THE INCIDENT WAS NOT PROVIDED. THE CPAP UNIT WAS NOT RETURNED, WHICH EMERGENT RESPIRATORY, LLC REQUESTED THE RETURN OF THIS UNIT, HOWEVER, RECEIVED NO RESPONSE TO THE REQUEST. IN REVIEW OF THE DEVICE HISTORY RECORD (DHR), THIS UNITS WAS MANUFACTURED IN DECEMBER 2004 AND DELIVERED TO THE CUSTOMER IN (B)(6) 2005. THE UNITS WAS RETURNED FOR INITIAL SERVICING IN (B)(4) 2013. NOTE: EMERGENT RESPIRATORY, LLC RECOMMENDS TO SERVICE THE UNIT EVERY 2 YEAR. THE UNIT WAS CONFIRMED FUNCTIONING PROPERLY DURING SERVICING.

    Description of Event or Problem · 1

    REF VOL REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289180 PROTOVENT CPAPOS CPAP BTL EMERGENT RESPIRATORY LLC 1900-001 ERP001-2/122804

    Patients

    Seq Age Sex Outcome Treatment
    1