BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HBO VENTILATOR

    MDR report key: 6094998 · Received November 10, 2016

    Report

    Report Number
    2020676-2016-00012
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 11, 2016
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED UNIT WAS MADE AVAILABLE TO THE MANUFACTURER FOR AN EVALUATION. SUMMARY: THE HBO HV-500A VENTILATOR UNIT, S/N (B)(4), WAS REPORTED BY THE CUSTOMER TO NOT COMPENSATE PROPERLY AT DEPTH, WITH AN APPROXIMATELY 50% DROP IN VOLUME. THE ISSUE WAS DISCOVERED DURING CLINICAL IN-SERVICE. THE UNIT WAS TESTED PER DOCUMENTS (B)(4) REV. 8 AND (B)(4) REV. 8. THE UNIT FAILED TO MEET THE SPECIFICATIONS LISTED IN STEPS 4.2.9, 4.2.5, AND 4.2.16 OF THE TEST AND INSPECTION DATA SHEET (DOCUMENT (B)(4)), HOWEVER DROPS IN VOLUME AT DEPTH OUTSIDE THE SPECIFICATIONS LISTED IN 4.2.21 AND 4.2.25 WERE NOT OBSERVED. THE COMPLAINT IS UNVERIFIED. PRODUCT EVALUATION: THE VENTILATOR UNIT WAS RECEIVED WITH THE WATER TRAP FITTING BROKEN OFF. THE INNER SURFACE OF THE SHIPPING BOX SHOWED MARKS WERE THE WATER TRAP MADE CONTACT. TESTING AS RECEIVED WAS THEREFORE NOT POSSIBLE. THE NIPPLE WAS REPLACED AND THE WATER TRAP INSTALLED BEFORE TESTING. A COSMETIC MARK ON THE RIGHT SIDE OF THE HOUSING WAS NOTED. THE VENTILATOR UNIT PROPERLY COMPENSATED THE TIDAL VOLUME AT THE DIFFERENT DEPTHS OUTLINED IN THE INSPECTION PROCEDURE. THE DROPS IN VOLUME RECORDED WERE WITHIN SPECIFICATIONS; AT TIDAL VOLUME 500 ML, ALL DATA POINTS WERE WITHIN THE ACCEPTABLE RANGE OF 500 ± 150 ML; AND AT TIDAL VOLUME 1000 ML, ALL DATA POINTS WERE WITHIN THE ACCEPTABLE RANGE OF 1000 ± 300 ML. ROOT CAUSE: THE CUSTOMER COMPLAINT OF AN APPROXIMATE 50% DROP IN VOLUME AT DEPTH COULD NOT BE VERIFIED. THE GREATEST DROP IN VOLUME RECORDED WAS DURING THE 4.2.25 1000 ML PROCEDURAL TEST AT 16%, WITHIN THE ACCEPTABLE RANGE. UNIT WAS TESTED AND REPAIRED TO MEET SPECIFICATIONS AND WAS RETURNED TO CUSTOMER ON 04/26/2017.

    Additional Manufacturer Narrative · 1

    THE VENTILATOR HAS NOT BEEN RETURNED FOR AN EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE SECHRIST WILL SUBMIT A FOLLOW UP REPORT. THIS REPORT IS SUBMITTED TO COMPLY WITH MDR MALFUNCTION NOTICE (B)(4) REQUIRING THE REPORTING OF INCIDENTS INVOLVING A LIFE-SUPPORTING AND/OR LIFE-SUSTAINING DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DOES NOT COMPENSATE PROPERLY AT DEPTH. VOLUME APPEARS TO DROP BY APPROXIMATELY 50%. PROBLEM WAS DISCOVERED DURING CLINICAL INSERVICE. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743414 HBO VENTILATOR VENTILATOR CBK SECHRIST INDUSTRIES, INC. HV-500A

    Patients

    Seq Age Sex Outcome Treatment
    1