BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2150535 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00222
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SVC REPORT: SYMPTOM - THE PUMP DID NOT RECOGNIZE THE FIBEROPTIC CONNECTION WHILE ON A PT. FINDINGS/ACTION TAKEN: BIOMED CHECKED THE PUMP WITH FIBEROPTIC TESTER AND REPORTED THAT IT WAS WORKING PROPERLY. REFERENCE MDR #1219856-2011-00206 AND MDR #1219856-2011-00207 FOR THE FIRST AND SECOND RELATED INTRA-AORTIC BALLOON REPORTS INVOLVING THE SAME PT. REFERENCE MDR #1219856-2011-00223 FOR THE RELATED INTRA-AORTIC BALLOON PUMP REPORT INVOLVING THE SAME PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON