BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 41

    MDR report key: 76513 · Received March 14, 1997

    Report

    Report Number
    1825511-1997-00014
    Event Type
    Injury
    Date Received
    March 14, 1997
    Date of Event
    January 26, 1997
    Report Date
    March 14, 1997
    Manufacturer
    PURITAN-BENNETT
    Product Code
    BYJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: FURTHER INVESTIGATION INDICATES THAT THE REPORTED PROBLEM MAY BE CONTRIBUTED TO CRACKS IN THE LIQUID LEVEL GAUGE (LLG) CAUSED BY NOT USING THE LEAK DETECTOR RECOMMENDED BY PURITAN-BENNETT. CO EVALUATED THE LEAK DETECTOR USED BY VCM IN COMPARISON TO CO'S RECOMMENDED LEAK DETECTOR. CO TESTED TWO NEW LLGS FROM IDENTICAL LOTS ON THE SAME STATIONARY LIQUID OXYGEN (LOX) UNIT BY ALTERNATING TESTING TIMES. THE STATIONARY UNIT WAS FILLED WITH LOX AND THE LEAK DETECTOR WAS APPLIED TO THE LLG WHILE IT WAS AT OPERATING PRESSURE FOR SEVERAL DAYS. THE LEAK DETECTOR USED BY VCM RESULTED IN CRACKS TO THE LLG WITHIN 24 HOURS. BY THE 6TH DAY, THE OPERATING PRESSURE BEGAN TO DROP, WHICH DUPLICATED THE REPORTED PROBLEM. THE RECOMMENDED LEAK DETECTOR DID NOT RESULT IN CRACKS TO THE LLG AND THE OPERATING PRESSURE REMAINED IN SPEC THROUGHOUT TESTING. CO CONCLUDES THAT THE LEAK DETECTOR USED BY VCM DAMAGED THE LLG WHICH RESULTED IN THE REPORTED PROBLEM. CO REITERATED THE CAUTIONS TO VCM OF USING ONLY THE RECOMMENDED LEAK DETECTOR, FORWARDED CO'S EVALUATION RESULTS, AND PROVIDED A SUPPLY OF CO'S LEAK DETECTOR FOR RESOLUTION.

    Description of Event or Problem · 1

    HOMECARE DEALER, VCM, REPORTED THAT A PT WAS USING A C41 WHICH MALFUNCTIONED CAUSING A "LOSS OF PRESSURE" AND THEREFORE LOW AND NO FLOW. THE PT WAS TAKEN TO HOSP AND ADMITTED ON 1/26/.97. SHE WAS TRANSFEREED TO A CONVALESCENT CENTER ON 1/29/97 AND RELEASED ON 2/7/97. SHE THEN UNDERWENT CARE AT HOME WITH PROFESSIONALS. THE HOSP WAS NOT AWARE THAT ALLEGEDLY PT'S C41 MALFUNCTIONED CAUSING THE PT TO BE ADMITTED TO HOSP, LIQUID OXYGEN SYSTEMS ARE NOT CONSIDERED LIFE-SUPPORTING AS STATED IN THE ENCLOSED PRODUCT LABELING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R