BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMITTENT SUCTION REGULATOR

    MDR report key: 971222 · Received May 7, 2007

    Report

    Report Number
    1419185-2007-00001
    Event Type
    Malfunction
    Date Received
    May 7, 2007
    Date of Event
    March 11, 2007
    Report Date
    April 17, 2007
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    KDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2007, OHIO MEDICAL CORPORATION WAS NOTIFIED OF A USER FACILITY REPORT SUBMITTED REGARDING AN ALLEGEDLY DEFECTIVE VACUUM REGULATOR THAT WAS MANUFACTURED BY OHIO MEDICAL IN AUGUST OF 1996. THE FACILITY WAS CONTACTED ON 4/17/2007 TO SEE IF THEY WOULD RETURN THE UNIT FOR INVESTIGATION. THEY WOULD NOT RETURN IT. ON 5/1/2007, THE FACILITY WAS AGAIN ASKED IF THEY WOULD RETURN THE UNIT AND THEY STATED THAT THEY WOULD NOT RETURN IT. THE ALLEGED MALFUNCTION COULD NOT BE DUPLICATED BY THE FACILITY AND NO FURTHER INFORMATION COULD BE OBTAINED FROM THE INSTITUTION. THE FACT THAT THE DEVICE HAS MALFUNCTIONED COULD NOT BE ESTABLISHED BY THE HOSP OR OHIO MEDICAL. BASED ON THE COMPANY'S EXTENSIVE EXPERIENCE WITH THIS PRODUCT, WE BELIEVE THERE IS NO HEALTH HAZARD INDICATED BY THIS REPORT AND NO FURTHER INFO WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD BEEN INTERMITTENTLY THROWING UP GREEN BILLIOUS FLUID DURING THE NIGHT. DURING ASSESSMENT AT 0900, NURSE FOUND THAT THE SUCTION HEAD WAS NOT FUNCTIONING. THE NASAL GASTRIC TUBE WAS HOOKED UP TO FUNCTIONING SUCTION HEAD. AFTER DEVICE REPLACED, ONE LITER FLUID DRAINED WITHIN THIRTY MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMITTENT SUCTION REGULATOR VACUUM REGULATOR KDP OHIO MEDICAL CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR