BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHIO MEDICAL

    MDR report key: 1396349 · Received June 1, 2009

    Report

    Report Number
    1419185-2009-11270
    Event Type
    Other
    Date Received
    June 1, 2009
    Date of Event
    October 20, 2008
    Report Date
    May 9, 2009
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    KDP
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE SUBJECT UNIT BY OHIO MEDICAL CORPORATION IS AS FOLLOWS: THE UNIT WAS FOUND TO HAVE BEEN IN A POSITION THAT DID NOT ALLOW THE REGULATOR ADJUSTING KNOB TO TURN, THEREBY LEAVING THE UNIT TO MAINTAIN FULL VAC. THIS OCCURRED BY TURNING THE KNOB TO POINT WHERE IT DISENGAGED THE REGULATOR MODULE FROM ITS CAVITY AND LEAVING THE REGULATOR IN A POSITION THAT IT WOULD NOT SCREW BACK INTO THE CAVITY. THE GAUGE IS SET SO THAT FROM THE FACTORY SETTING OF 100 MMHG, A 3/4 TURN WILL GIVE "FULL VAC" LEAVING THE KNOB A BUFFER OF 1/2 TURN MEANING THAT YOU CAN REACH FULL VAC AND STILL HAVE A QUARTER TURN BEFORE YOU REACH RESISTANCE FROM THE KNOB. YOU CAN REACH "FULL VAC" FROM ZERO IN 1 1/2 TURNS WITH 1/4 TURN BUFFER. THE GAUGE WAS TESTED TO THESE PARAMETERS AND PASSED, NEGATING ANY QUESTIONS OF THE NEEDLE NOT REACHING "FULL VAC" WHERE THE OPERATOR NEEDED TO KEEP TURNING THE KNOB TO REACH FULL VAC. IT APPEARS THAT THE USER WAS UNAWARE THAT A MAXIMUM OF 1 1/2 TURNS WERE NEEDED IN ORDER TO REACH FULL VAC (OUR LEGACY MODEL NEEDED 6 1/2 TURNS FROM ZERO TO FULL VAC) OR WAS INATTENTIVE WHILE SETTING THE VAC LEVEL.

    Description of Event or Problem · 1

    (B)(6) HOSPITAL, (B)(6), CALLED OHIO MEDICAL CORPORATION ON (B)(6) 2008 TOP REPORT AN INCIDENT INVOLVING A SUCTION REGULATOR MADE BY OHIO MEDICAL CORPORATION. MR. (B)(6) WAS THE BIOMEDICAL TECHNICIAN REPORTING THE INCIDENT. MR.(B)(6) REPORTED THAT APPROXIMATELY 15 MINUTES AFTER MOVING THE PATIENT, WITH TWO CHEST TUBES INSERTED AND CONNECTED TO A CHEST DRAINAGE UNIT AND TO AN OHIO MEDICAL PTS IUS SUCTION DEVICE, FROM ICU ROOM TO THE TELEMETRY ROOM, THE PATIENT REPORTED TROUBLE BREATHING (DISCOMFORT AND SHORTNESS OF BREATH). WHEN ASSESSED, IT WAS FOUND "HIS CHEST WAS EXPANDING" AND THOUGHT TO BE CAUSED BY FLUID BACKUP. THE PTS ISU DEVICE IN QUESTION WAS REPLACED WITH ANOTHER UNIT AND NO FURTHER INTERVENTION WAS NECESSARY. FURTHER INFORMATION FROM THE HOSPITAL WAS OBTAINED AND THE UNIT WAS RETURNED FOR INVESTIGATION. FROM THIS INFORMATION, IT WAS DETERMINED THAT THE PRODUCT DID NOT FAIL TO MEET LABEL CLAIMS AND THE INCIDENT WAS NOT A MALFUNCTION ATTRIBUTED TO INCORRECT/MISSING INSTRUCTIONS FOR USE. THE DEVICE WAS USED FOR ITS INTENDED USE. THE INCIDENT DID NOT INVOLVE DEATH OR SERIOUS INJURY. MEDICAL INTERVENTION WAS NOT NECESSARY TO TREAT, PREVENT, OR AVOID DAMAGE OR IMPAIRMENT TO THE BODY, NOR DID THE ISSUE WITH THE DEVICE LEAD TO DELAY IN TREATMENT THAT CAUSED SERIOUS INJURY TO THE PATIENT. MEDICAL INTERVENTION WAS NOT REQUIRED TO PRECLUDE IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE. THERE WAS NO MALFUNCTION OF THE DEVICE THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE DEATH OR SERIOUS INJURY. MR. (B)(6) STATED THAT THE DEVICE HAD BEEN SET UP INAPPROPRIATELY BY THE CLINICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHIO MEDICAL PTS ISU KDP OHIO MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other