BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA COMPREHENSIVE VENTLATOR

    MDR report key: 3973244 · Received June 6, 2014

    Report

    Report Number
    2021710-2014-00030
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT WAS IDENTIFIED AS A LATE SUBMISSION DURING A TWO YEAR RETROSPECTIVE REVIEW OF COMPLAINTS AND MDR¿S FOLLOWING RECEIPT OF AN UNTITLED LETTER ISSUED BY THE FDA. THE ORIGINAL DATE OF AWARENESS IS (B)(6) 2014; THIS INFORMATION WAS NOTED ON 9/21/2015. THIS EVENT WAS AN ADVERSE EVENT AS WELL AS A PRODUCT MALFUNCTION. MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY OR DEATH. LIFE THREATENING AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. (DEVICES) WERE ADDED BECAUSE THE VENTILATOR REQUIRED CHANGE OUT. BRAND NAME: AVEA COMPREHENSIVE VENTILATOR. INFORMATION REDACTED FROM INITIAL MDR, SUBMITTED IN ERROR. SHOULD BE CODED AS SERIOUS INJURY GIVEN MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY OR DEATH.

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF CALLS RELATED TO THIS VENTILATOR IT WAS DETERMINED THAT THE UIM WAS REPLACED AND RETURNED TO CAREFUSION FOR ANALYSIS. THE CAREFUSION TECHNICAL SUPPORT SPECIALIST IN CONJUNCTION WITH THE CUSTOMER HAS DETERMINED THAT THE PROBABLE CAUSE OF THE REPORT EVENT WAS A FAULTY UIM P/N #16448 TO BE FORWARD TO CAREFUSION FACTORY SERVICE/TECH II REPAIR DEPT. ON RMA (B)(4) TO BE EVALUATED / REPAIR. THE COMPONENT WITH THE ALLEGED MALFUNCTION HAS BEEN RECEIVED BY AND THE REPAIR TECH FOUND AND ISOLATED ROOT CAUSE WAS A DEFECTIVE CONTROL PCBA BOARD P/N #52340 SN (B)(4). THIS IS A KNOWN ISSUE WHICH HAS BEEN ADDRESSED BY AN INTERNAL CORRECTIVE ACTION. CONTROL PCBA BOARD AND MISSING CABLE ASSEMBLY P/N #51000-40688 WERE REPLACED AND COMPLETED 4.6 SOFTWARE DOWNLOAD. PERFORM TEST AND A COMPLETE CHECKOUT TO ENSURE THE UNIT MEETS FACTORY SPECS. THE ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MALFUNCTION. NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A CONTRACTED THIRD PARTY SERVICE COMPANY REP. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE BY THE USER FACILITY CONTRACTED THIRD PARTY SERVICE COMPANY WAS DOCUMENTED BY A CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A THIRD PARTY SERVICE COMPANY REPRESENTATIVE. THE DEVICE WAS EVALUATED BY THE USER FACILITY RT DEPT AND THE USER FACILITY'S CONTRACTED THIRD PARTY SERVICE CO REP AND NEITHER OF THEM DUPLICATED THE REPORTED ALLEGED EVENT. AS A PRECAUTION THE USER FACILITY'S CONTRACTED THIRD PARTY SERVICE CO REP ADVISED THE USER FACILITY TO REPLACE THE GAS DELIVERY ENGINE (GDE). ON (B)(4) 2014, THE USER FACILITY'S CONTRACTED THIRD PARTY SERVICE CO REP REPORTED TO CAREFUSION THAT DUE TO USER FACILITY BUDGET CONSTRAINTS THE GAS DELIVERY ENGINE HAS NOT BEEN REPLACED. CAREFUSION SEND A LETTER VIA EMAIL TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT, THE CONDITION OF THE PATIENT AND CURRENT STATUS OF THE DEVICE. AS ON JUNE 5 2014 THERE AHS BEEN NO RESPONSE FROM THE USER FACILITY. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY CONTRACTED THIRD PARTY SERVICE COMPANY REPRESENTATIVE. "VENT WAS ON PATIENT, NO INJURY, RT SAID THEY HEARD ALARM FROM SATURATION MONITOR. THEY SAID THEY LOOKED AT THE PATIENT AND NOTICED THERE WERE NO CHEST EXCURSIONS. QUICKLY CHECKED CIRCUIT WHICH SEEMED TO BE OK. VENT WAS NOT DELIVERING ANY BREATHS TO THE PATIENT AND THERE WERE NO AUDIBLE OR VISUAL ALARMS PRESENT FROM THE VENT. THEY TRIED TO MAKE CHANGES ON UIM BUT COULD NOT. UIM WAS ON BUT WAS FROZEN AND WOULD NOT LET THEM CHANGE ANYTHING. PATIENT WAS THEN BAGGED AND PLACED ON ANOTHER VENT. [NAME REMOVED] SAYS THE RT DEPT TESTED THE VENT A FEW DAYS LATER AND IT RAN FINE, COULD NOT DUPLICATE. [NAME REMOVED] HAS RUN THE VENT FOR A COUPLE HOURS AND ALSO CANNOT DUPLICATE THE PROBLEM. VENT IS RUNNING 4.6 SFWR AND HAS ORIGINAL AJ S/N GDE IN IT. ASKED IF HE WOULD LIKE TO SEND VENT IN FOR FACTORY TESTING HE SAID NO, HE JUST WANTS TO REPORT THIS INCIDENT. HE IS GOING TO RECOMMEND TO HOSPITAL TO REPLACE THE GDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331539 AVEA COMPREHENSIVE VENTLATOR CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU Life Threatening| R