BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE INTRA-AORTIC PUMP

    MDR report key: 3897625 · Received May 15, 2014

    Report

    Report Number
    2249723-2014-00325
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE SVC REPORT IS AS FOLLOWS: ALARMS PRESENT: FOS CONTINUOUS BIT FAILED/DSPAPERIODICDATAACQ. LINE: 418 ARG 1 0X0 AND 0XC00C, ARG 2 0X0. RAN FIBER OPTIC TEST PWM 40 LAMP OUTPUT: 159. RESULT: NO FOS ERRORS. REPLACED 0997-00-1162E. NEW BOARD, PWM 51 LAMP OUTPUT 241 SIGNAL COUNT 163 SIGNAL LEVEL 164 IF THE UNIT/PART IS RETURNED FOR EVAL AND UP ON RESULTS AVAILABILITY A SUPPLEMENT DOCUMENT WILL BE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: FIBER-OPTIC MODULAR ALARM..WHEN CABLE IS PLUGGED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292642 DATASCOPE INTRA-AORTIC PUMP CARDIOSAVE DSP DATASCOPE CORP CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1