BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE-E-VAC III

    MDR report key: 1699258 · Received May 3, 2010

    Report

    Report Number
    1419185-2010-14520
    Event Type
    Malfunction
    Date Received
    May 3, 2010
    Date of Event
    April 12, 2010
    Report Date
    May 14, 2010
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED UPON THE ANALYSIS OF TECNOVA AND THE TESTING PER PROTOCOL #0014, IT IS DETERMINED THAT THE CARE-E-VAC 3 CIRCUIT BOARD PART NUMBER 758052 DOES NOT REQUIRE DIODE D14 TO OPERATE. DIODE D14 CAN OVERHEAT WHEN A SERIES OF SPECIFIC EVENTS OCCUR CAUSING SMOKE AND A BURNING SMELL BUT POSES NO PT SAFETY RISK. OF THE 15 REPORTED INCIDENTS, NO PTS WERE HARMED. CIRCUIT BOARD PART NUMBER 758052 CONTINUES TO OPERATE AS DESIGNED WITHOUT THE USE OF DIODE D14 WHICH, AS NOTED BY THE CIRCUIT BOARD EXPERTS, IS NOT A NECESSARY DIODE. WITH THE LIMITED FAILURE RATE OF 0.412% AND THE NEGLIGIBLE RISK TO PT AND USER SAFETY, IT WAS DECIDED NOT TO RECALL UNITS AT THIS TIME. MOVING FORWARD, WE WILL CONTINUE TO MONITOR THE COMPLAINTS AND CHANGE OUT ALL CARE-E-VAC III CIRCUIT BOARDS TO THE UPDATED REV 5 CIRCUIT BOARD IN UNITS RETURNED FOR SERVICE. FURTHERMORE, CAPA (B)(4) HAS BEEN INITIATED TO EVALUATE PREVENTIVE ACTIONS WITH REGARD TO THE CARE-E-VAC III UNITS IN THE FIELD THAT CONTAIN THE PREVIOUS CIRCUIT BOARD REVISION CONTAINING DIODE 14. A FOLLOW UP REPORT #2 WILL BE PROVIDED ONCE PREVENTIVE ACTIONS HAVE BEEN IDENTIFIED AND EVALUATED. RATIONALE SURROUNDING ANY ADDITIONAL ACTIONS OR NO ACTION WILL ALSO BE DISCUSSED UNDER CAPA (B)(4) AND INCLUDED IN THE FOLLOW-UP REPORT #2 WITH REGARD TO THIS EVENT.

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THE UNIT HAD AN SMALL ELECTRICAL BURN AND RETURNED IT TO OHIO MEDICAL CORPORATION FOR EVAL AND REPAIR. THE UNIT WAS EVALUATED BY OHIO MEDICAL CORPORATION'S REPAIR PERSONNEL. THE UNIT WAS FOUND TO HAVE A BURNED CIRCUIT PANEL. THE UNIT WAS RETAINED FOR FURTHER EVAL. A REPLACEMENT WAS SENT TO THE CUSTOMER. THIS EVENT DID NOT CONTRIBUTE TO A DEATH, ILLNESS OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARE-E-VAC III PORTABLE SUCTION DEVICE BTA OHIO MEDICAL CORPORATION 3 CEB061055

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other