BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 729210 · Received June 20, 2006

    Report

    Report Number
    2031702-2006-00146
    Event Type
    Malfunction
    Date Received
    June 20, 2006
    Report Date
    June 20, 2006
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT REPORTEDLY HAD TWO UNITS FOR HOME CARE USE; PRIMARY VENT WAS AN LTV 800, CATALOG # 11800-99, WHICH WAS RETURNED TO THE MANUFACTURER IN 2006 AND REPORTED UNDER MANUFACTURER REPORT NUMBER: 2031702-2006-00126. THE MANFACTURER WAS UNABLE TO DUPLICATE THE REPORTED SHUT DOWN.

    Description of Event or Problem · 1

    THE PATIENT'S SON REPORTED, OVER THE PAST THREE NIGHTS, HIS FATHER WAS AWAKEND NUMEROUS TIMES BY THE UNIT MALFUNCTIONING MANY TIMES. THE FIRST MORNING, AFTER THE FIRST MALFUNCTION, HE ACTUALLY HAD A MINI SEIZURE. THE HOMECARE PROVIDER WAS NOTIFIED AND THE UNIT WAS IMMEDIATELY EXCHANGED. THE NEXT NIGHT, THE VENTILATOR AGAIN MALFUNCTIONED AND THE SON MADE A QUICK CHANGE IN THE CIRCUT, WHICH SEEMED TO CHANGE IT A LITTLE. THE PATIENT WENT THROUGH THE REST OF THE NIGHT AND THE DAY PROBLEM FREE. THE LAST NIGHT, ABOUT 5 MINUTES AFTER THE PATIENT WENT TO SLEEP, HIS VENTILATOR IMMEDIATELY SHUT OFF, AND HE WAS NOT RECEIVING ANY AIR. THE PATIENT HAD TWO UNITS (ONE FOR HIS WHEELCHAIR AND ONE FOR HIS BED) SO THE SON SWITCHED THEM OUT AND STILL NEITHER OF THEM WOULD WORK. SOMEONE GRABBED ON AMBU BAG AND ASSISTED THE PATIENT, WHILE THE SON CALLED ON AMBULANCE. THE PATIENT WAS TAKEN TO INTENSIVE CARE. DURING THE MANUFACTURER'S REQUEST FOR ADDITIONAL INFORMATION, THE HOMECARE PROVIDER STATED " THE PATIENT WAS ADMITTED TO THE ICU AS THIS IS A SMALL HOSPITAL AND THAT IS THE ONLY PLACE THEY CAN PUT HIM. HE BELIEVES THE PATIENT STAYED OVERNIGHT AND WAS RELEASED THE FOLLOWING DAY; PATIENT REPORTEDLY WAS FINE AND DID NOT BLAME THE VENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK PULMONETIC SYSTEMS, INC. LTV 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *