BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 6911053 · Received October 3, 2017

    Report

    Report Number
    2031642-2017-03162
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 22, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTHORIZED SERVICE PROVIDER, (B)(6), CONFIRMED THERE WERE NO FAILURES WITH THE VENTILATOR. IT WAS CONFIRMED THAT GASTRIC DILATION WAS A DESCRIBED SIDE EFFECT IN THE USER MANUAL. THE CLINICAL STAFF AT THE HOSPITAL WAS GIVEN FURTHER TRAINING ON THIS.

    Additional Manufacturer Narrative · 1

    THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE ADVERSE EVENT]. GASTRIC DISTENTION IS A KNOWN PATIENT ISSUE WITH POSITIVE PRESSURE VENTILATION.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A PATIENT HAD GASTRIC DISTENTION. THE PATIENT WAS ADMITTED FOR ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HEART DISEASE, TYPE 2 RESPIRATORY FAILURE, RESPIRATORY ACIDOSIS, METABOLIC ALKALOSIS AND HYPERPLASIA OF THE PROSTATE. THE PATIENT WAS ON THE VENTILATOR FOR APPROXIMATELY ONE WEEK FOR FOUR HOURS A DAY, AND ON (B)(6) 2017, HAD AIR LEAKAGE OF 7 20/L, THE PATIENT HAD FLATULENCE AND IT WAS VISIBLE. THE VENTILATOR WAS REMOVED AND THE PATIENT WAS TREATED WITH TONGLI SHENLING GRANULES 10 G FOR SPLEEN AND STOMACH THREE TIMES A DAY) AND DOMPERIDONE MALEATE TABS 12.7 MG. AFTER ONE WEEK OF TREATMENT THE PATIENT HAS NO FURTHER SYMPTOMS AND DID NOT REQUIRE A NASO-GASTRIC TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692067 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention