BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCEAN WET SUCTION WATER SEAL DR

    MDR report key: 2240946 · Received September 2, 2011

    Report

    Report Number
    1219977-2011-00008
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 4, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    KDQ
    PMA / PMN Number
    K043582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT. IT IS NOTED THAT THE DEVICE WAS USED 2 MONTHS PAST THE EXP DATE. THIS DEVICE HAS A 5 YR SHELF LIFE. INCIDENT IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    INFO OBTAINED FROM MAUDE EVENT REPORT SENT BY FDA: A GESTATION INFANT WHO WAS BORN BY AUGMENTED VAGINAL DELIVERY PRESENTED WITH MILD RESPIRATORY DISTRESS WITH RETRACTIONS AND EXPIRATORY GRUNTING, APGAR SCORES WERE 8 AND 9. INFANT RECEIVED MASK CRAP AND BMV IN THE DELIVERY ROOM AND WAS TRANSFERRED TO INTENSIVE CARE NURSERY WITHOUT INCIDENT ON NCPAP. ON DAY OF (B) (6) INFANT DEVELOPED A RIGHT SIDED TENSION PNEUMOTHORAX THAT WAS NEEDED X2 AND THEN REQUIRED A CHEST TUBE PLACEMENT. A PLEUROVAC WAS SET UP IN "USUAL FASHION" (CONNECTED TO WALL SUCTION). THE CHEST TUBE WAS CONNECTED TO PLEUROVAC AND NO "BUBBLING" WAS NOTED AT THAT TIME. INFANT'S CONDITION DETERIORATED WITH INCREASING CO2 LEVELS AND LABORED "BREATHING." INFANT WAS THEN REINTUBATED BY PHYSICIAN. A SECOND (REPLACEMENT) PLEUROVAC WAS SET UP IN "USUAL FASHION". (CONNECTED TO WALL SUCTION) AND CHEST TUBE. INFANT THEN EXPERIENCED RAPID IMPROVEMENT WITH DECREASING CO2 LEVELS AND LABORED BREATHING. ON (B) (6) 2011, INFANT EXTUBATED WITHOUT COMPLICATIONS AND REMAINS UNDER INTENSIVE CARE SVC FOR OTHER "PREMATURITY" RELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCEAN WET SUCTION WATER SEAL DR THORACIC DRAIN, WATER SEAL (KDQ) KDQ ATRIUM MEDICAL CORP. 651201 10496405

    Patients

    Seq Age Sex Outcome Treatment
    1 Other