BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3144732 · Received May 31, 2013

    Report

    Report Number
    2520313-2013-00029
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    February 12, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDRAD
    Product Code
    DQA
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R AND I PRODUCT ANALYSIS RECEIVED AND EXAMINED THE CHARGER AND DC POWER CABLE. THE CHARGER WAS FOUND TO BE NON-FUNCTIONAL DUE TO BLOWN LINE FUSES. THE POWER CABLE WAS EXAMINED AND FOUND TO HAVE BROKEN AND SHORTED WIRES INSIDE. THE SHORT CIRCUIT OF THE DC POWER CABLE LIKELY LED TO THE BLOWN FUSES ON THE POWER SUPPLY. THE OPERATION MANUAL STATES THE BATTERY ICONS ARE DESIGNED TO INFORM THE USER OF THE REMAINING BATTERY LIFE. A GREEN COLORED ICON INDICATES AT LEAST 1 HOUR OF BATTERY LIFE REMAINING, A YELLOW COLORED ICON INDICATES THE BATTERY IS WEAK, (LESS THAN 1 HOUR AND MORE THAN 15 MINUTES OF CHARGE REMAINS), AND A BLACK COLORED ICON INDICATES THERE IS NO BATTERY LIFE REMAINING AND THE MONITOR IS ABOUT TO POWER OFF. THE NON-FUNCTIONAL CONDITION OF THE POWER SUPPLY AND THE DAMAGED DC POWER CABLE WOULD HAVE RESULTED IN BOTH YELLOW AND BLACK INDICATOR LIGHTS BEING DISPLAYED ON THE MONITOR ALERTING THE USER THAT SERVICE WAS NEEDED. ACCORDING TO THE INVESTIGATION REPORT, THE REPORTED SYMPTOM OCCURRED DUE TO AN INSUFFICIENT CHARGE OF THE SYSTEM BATTERY THAT WAS CAUSED BY THE INOPERATIVE POWER SUPPLY. THE INVESTIGATION REPORT ALSO CONCLUDED THAT PERSONNEL AT THE SITE CHOSE TO CONTINUE USING THE MONITOR DESPITE THE LOW BATTERY WARNING. ON (B)(4) 2013, BAYER HEALTHCARE DISTRIBUTED A FIELD SAFETY NOTICE RECALLING ALL 25-FOOT DC POWER CABLES SHIPPED WITH VERIS MEDRAD MR VITAL MONITORS. BAYER R AND I HAS MADE TWO ATTEMPTS THUS FAR, TO GAIN A RESPONSE FROM THE SITE AND RECEIVED A CERTIFIED MAIL RECEIPT THAT THE SITE RECEIVED THE RECALL NOTICE; HOWEVER, TO DATE, THE SITE HAS NOT RESPONDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A BAYER R AND I SENIOR CLINICAL SUPPORT SPECIALIST REPORTED THE SITE TOLD HER THE FOLLOWING INFO DURING A SITE VISIT: DURING AN ANESTHESIA ASSISTED SEDATION CASE, THE VERIS MONITOR STOPPED WORKING. THE PT CODED AND REQUIRED MEDICAL INTERVENTION REQUIRING TRANSPORT TO THE EMERGENCY ROOM, RESUSCITATION WHERE THEY RECOVERED, AND AN ADD'L THREE DAY HOSPITAL ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240743 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITRO, PHYSIOLOGICAL PATIENT DQA MEDRAD 3011996

    Patients

    Seq Age Sex Outcome Treatment
    1