BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE-E-VAC III

    MDR report key: 3394605 · Received September 18, 2013

    Report

    Report Number
    1419185-2013-00003
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Report Date
    September 17, 2013
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    PMA / PMN Number
    K062610
    Removal / Correction Number
    Z-0833-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS EVALUATED BY THE ENGINEERING DEPARTMENT AT OHIO MEDICAL CORPORATION. UPON INVESTIGATION, IT WAS IDENTIFIED THAT THE UNIT CONTAINED AN OLD PC BOARD (PART NUMBER 758052 REV. 2). THIS ISSUE IS RELATED A DEFECT WHICH IS IDENTIFIED IN OHIO MEDICAL CORPORATION'S CAPA SYSTEM. THE DEVICE IN QUESTION WAS THE SUBJECT OF RECALL NUMBER Z-0833-2011. THE USER FACILITY FOR THIS UNIT (UNIT CDF0000129) WAS NOTIFIED PER THE RECALL PROCEDURE. A MINIMUM OF THREE (3) ATTEMPTS HAD BEEN MADE TO NOTIFY THE CUSTOMER OF THE FIELD CORRECTIVE ACTION. THE ATTEMPTS INSTRUCTED THE CUSTOMER TO RETURN THE UNIT TO OHIO MEDICAL CORPORATION FOR REPAIR OR TO REQUEST SERVICE AT THEIR SITE FOR THE REPAIR OF THE UNIT. THE CUSTOMER DID NOT RESPOND TO THE ATTEMPTS MADE BY OHIO MEDICAL CORPORATION. THIS FIELD CORRECTIVE ACTION WAS CLOSED BY FDA ON 03/16/2012.

    Description of Event or Problem · 1

    (B)(4) MEDICAL CORP WAS NOTIFIED BY (B)(6) (BIOMEDICAL ENGINEER AT (B)(6) STATE UNIVERSITY). (B)(6) STATED THAT THE UNIT HAD A FIRE INSIDE OF SHROUD. (B)(6) STATED THE UNIT WAS PLUGGED IN AND WAS CHARGING. A NURSE NOTICED A SMELL BUT DIDN'T THINK ANYTHING OF IT. THE NURSE UNPLUGGED THE UNIT TO USE IT AND IT WOULDN'T OPERATE ON THE BATTERY HOWEVER, IT DID OPERATE WHEN IT WAS PLUGGED IN TO AC. THEY DECIDED TO USE A DIFFERENT UNIT. THE NURSE THEN CALLED (B)(6) TO HAVE HIM REPAIR UNIT. WHEN HE OPENED THE UNIT, (B)(6) SAID THAT THE UNIT WAS SCORCHED INTERNALLY FROM A FIRE WITHIN THE UNIT AND THAT THE CASE CONTAINED THE FIRE. THE PC BOARD WAS HALF DISINTEGRATED, THE WIRE HARNESS WAS MELTED AND THE BATTERY LOOKED AS THOUGH IT HAS DAMAGE AS WELL. THIS EVENT DID NOT CONTRIBUTE TO A DEATH, ILLNESS OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470512 CARE-E-VAC III PORTABLE SUCTION DEVICE BTA OHIO MEDICAL CORPORATION 758000 CEB061064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA