BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 6910209 · Received October 3, 2017

    Report

    Report Number
    2031642-2017-03151
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    August 10, 2017
    Report Date
    September 22, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    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 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.

    Additional Manufacturer Narrative · 1

    THE AUTHORIZED SERVICE PROVIDER, (B)(4), 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 WERE GIVEN FURTHER TRAINING ON THIS.

    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 HYPERTENSION. THE PATIENT WAS ON THE VENTILATOR FOR APPROXIMATELY ONE WEEK, AND ON (B)(6) 2017, THE PATIENT HAD FLATULENCE, COULD NOT LIE SUPINE AND HAD CHEST TIGHTNESS. THE VENTILATOR WAS REMOVED AND THE PATIENT WAS TREATED WITH TONGLI SHENLING GRAUNULES 10G FOR SPLEEN AND STOMACH THREE TIMES A DAY) AND DOMPERIODONE MALEATE TABS 12.7MG. AFTER ONE WEEK OF TREATMENT THE PATIENT HAS NO FURTHER SYMPTOMS AND THE NASO-GASTRIC TUBE WAS NOT REQUIRED ANY LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690051 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention