BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPANION 41

    MDR report key: 90838 · Received May 9, 1997

    Report

    Report Number
    1825511-1997-00022
    Event Type
    Death
    Date Received
    May 9, 1997
    Date of Event
    March 10, 1995
    Report Date
    May 9, 1997
    Manufacturer
    PURITAN-BENNETT CORP.
    Product Code
    BYJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOMECARE PROVIDER (HCP) REPORTED THAT THE C41 WAS ORIGINALLY DELIVERED TO THE PT ON 3/3/95. ON 3/10/95, THE C41 WAS REFILLED WITH LIQUID OXYGEN (LOX), WHICH SHOULD HAVE SUPPLIED OXYGEN UNTIL 3/19/95 WITH FLOWS SET AT 2.5 LPM. ON 3/13, THE PT CALLED TO REPORT A LOSS OF PRESSURE AND WAS TAKEN TO THE HOSP. A FRIEND OF THE PT REPORTED THE FOLLOWING FINDINGS WHEN THE INCIDENT OCCURRED: A)THE FLOW WAS SET ON 2.5 LPM, BUT HAD NO FLOW, AND B) THAT THE LLG (LIQUID LEVEL GAUGE/CONTENTS INDICATOR) READ "FULL" WHEN THE UNIT WAS ACTUALLY EMPTY. THE C41 WAS RETURNED FOR OUR PARTIAL EVALUATION. FOLLOWING ARE THE RESULTS. "LOSS OF PRESSURE" REPORTED PROBLEM: THE C41 PASSED ALL FUNCTIONAL TESTS AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED. "NO FLOW" REPORTED PROBLEM: THE FLOW CONTROL VALVE (FCV) WAS WITHIN SPECIFICATION. THE FCV KNOB NEEDED ADJUSTMENT AS IT DID NOT ALWAYS ACCURATELY VISUALLY DEPICT THE ACTUAL FLOW SETTING, ALTHOUGH THE "CLICK" SET POINTS WERE ALWAYS ACCURATE. AN OBSERVER RELYING SOLELY ON THE VISUAL LABEL OF THE FCV KNOB COULD POSSIBLY HAVE PERCEIVED A NO FLOW PROBLEM WHEN THE FLOW WAS VISUALLY SELECTED AT 2.5 LPM. "LLG" REPORTED PROBLEM: CO WAS NOT ABLE TO TEST THIS PROBLEM PRIOR TO RETURNING THE UNIT TO THE HCP. CONCLUSION: THE RESULTS OF OUR EVALUATION ARE INCONCLUSIVE BASED ON CURRENT INFO. THE UNIT WAS RETURNED UNREPAIRED DUE TO LITIGATION AGAINST THE HCP.

    Description of Event or Problem · 1

    THE HOME CARE PROVIDER'S LAWYER REPORTED THEY WERE SERVED WITH A LAWSUIT IN WHICH THE PT'S ESTATE ALLEGES THAT THE PT WAS NOT RECEIVING ENOUGH OXYGEN FOR A PERIOD OF AFEW DAYS AROUND MARCH 10, 1995 AND THE COMPANION 41 STATIONARY LIQUID OXYGEN SYSTEM HAD A LOSS OF PRESSURE. THE PT DIED APRIL 18, 1995 REPORTEDLY OF ACUTE COPD AND DIVERTICULITIS (RESULTING IN RUPTURE DIVERTICULUM). THE HOME CARE PROVIDER EVALUATED THE UNIT AND FOUND NO DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION 41 STATIONARY LIQUID OXYGEN SYSTEM BYJ PURITAN-BENNETT CORP. C41 88011825

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death