BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTLAB LLC

    MDR report key: 18743617 · Received February 20, 2024

    Report

    Report Number
    1314417-2024-00013
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    January 19, 2024
    Report Date
    February 20, 2024
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    NHK
    UDI-DI
    10889483105214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT IN THE PACU REQUIRED SUPPORT WITH BREATHING. THE PEEPS' INABILITY TO DIAL INTO THE APPROPRIATE SETTING WOULD CAUSE THE NEONATES OXYGEN SATURATION TO DROP. THIS DELAYED THERAPY AND CAUSED THE NEONATE TO BE PUT ON A VENTILATOR. THE COMPLAINT OF " THE PEEP ON THE MANOMETER WASN'T WORKING CORRECTLY." REGARDING PART (B)(6) WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED SINCE THE ISSUE DESCRIBED BY THE CUSTOMER COULD NOT BE REPLICATED DURING FUNCTIONAL TESTING. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    THE PATIENT IN THE PACU REQUIRED SUPPORT WITH BREATHING. THE PEEPS' INABILITY TO DIAL INTO THE APPROPRIATE SETTING WOULD CAUSE THE NEONATES OXYGEN SATURATION TO DROP. THIS DELAYED THERAPY AND CAUSED THE NEONATE TO BE PUT ON A VENTILATOR.

    Description of Event or Problem · 0

    THE PEEP ON THE MANOMETER WASN'T WORKING CORRECTLY. THE PATIENT WAS PUT ON A VENT.

    Description of Event or Problem · 0

    THE PEEP ON THE MANOMETER WASN'T WORKING CORRECTLY. THE PATIENT WAS PUT ON A VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379124 VENTLAB LLC .5 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER NHK SUNMED HOLDINGS LLC HS4051 230600467 10889483105214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other