BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 3001987 · Received March 11, 2013

    Report

    Report Number
    1219856-2013-00064
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - REPORTED BY THE CARDIAC CATH LAB THAT "BALLOON PUMP NOT RECOGNIZING THE EKG TRIGGER." PUMP WAS ON PATIENT. FINDINGS/ACTION TAKEN: OBSERVED NO ECG SIGNAL ON LEAD I AND V USING CUSTOMERS ECG CABLE. OBSERVED ALL ECG SIGNAL LEAD I, II, III AND V USING MY (FIELD SERVICE REPRESENTATIVE) TEST ECG 5 LEAD CABLE. CUSTOMERS CABLE IS A 5 LEAD ECG CABLE P/N (B)(4) PROVIDED BY ARROW. UNIT PASSED FUNCTIONAL CHECK OUT. THE PUMP IS BACK IN SERVICE. SOFTWARE LEVEL 2.24. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 FROM THE FIELD SERVICE REPRESENTATIVE (FSR) WHO SPOKE WITH THE BIOMED THAT PLACED THE SERVICE CALL TO OUR FSR STATED THAT THE BIOMED HAS NO INFORMATION ABOUT THE PUMP OTHER THAN THE LOSS OF EKG TRIGGER. THE PUMP WAS DELIVERED TO HIS DEPARTMENT WITH A NOTE ON IT STATING THE PROBLEM. NO OTHER INFORMATION WAS GIVEN TO HIM. ALL THAT OUR FSR FOUND WAS A DEFECTIVE EKG CABLE AND THE HOSPITAL HAS ORDERED A NEW CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101554 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON