BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8043316-2019-00001

    MDR report key: 8657900 · Received May 31, 2019

    Report

    Report Number
    8043316-2019-00001
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 22, 2019
    PMA / PMN Number
    K110383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER FEEDBACK WAS RECEIVED AT (B)(6) 2019 AND FILED IN THE SAP SYSTEM. REQUEST CUSTOMER RETURN THE DEFECT PRODUCT. RECALL INITIATED, AND PRODUCT IMPROVEMENT STUDY IS ON-GOING BY ENGINEERING TEAM.

    Description of Event or Problem · 1

    CLINICIAN STATED THAT THE BUBBLE CONTINUOUS POSITIVE AIRWAY PRESSURE (BCPAP) SYSTEM WOULD NOT HOLD PRESSURE WHEN INITIALLY SET UP ON PATIENT. CLINICIAN NOTED THAT THE PRESSURE RELIEF MANIFOLD (PRM) INTERNAL MECHANISM WAS NOT SEATED WITH LOSS OF PRESSURE OUT THE TOP OF PRM. CLINICIAN STATED THAT THIS IS NOT THE FIRST INCIDENCE WITH LOT NUMBER 181127. PRODUCT AVAILABLE FOR REVIEW/WILL BE SENT TO RESIPRALOGICS, A DISTRIBUTOR OF (B)(6).

    Patients

    Seq Age Sex Outcome Treatment
    1