BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 2072834 · Received March 31, 2011

    Report

    Report Number
    2249723-2011-00031
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATASCOPE'S DISTRIBUTOR IN SINGAPORE, (IDS) REPORTED THAT THE UNIT HAS MORE THAN 8,000 HOURS OF USE AND THAT NO PREVENTATIVE MAINTENANCE WAS PERFORMED AT 2,500 OR 5,000 HOURS AS SPECIFIED IN THE OPERATOR'S MANUAL. THE DISTRIBUTOR THOROUGHLY INVESTIGATED THE INCIDENT WHICH INCLUDED RETRAINING IN PROPER PREVENTATIVE MAINTENANCE PROCEDURES. THE CAUSE OF THE PROBLEM WAS IDENTIFIED BY THE DISTRIBUTOR AS AN ISOLATED OCCURRENCE DUE TO HUMAN ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PATIENT, THE UNIT SHUTDOWN. THE PATIENT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED. THE CUSTOMER ALSO REPORTED THAT SIMILAR EVENTS OCCURRED PREVIOUSLY ON THIS UNIT. IN (B)(6) 2010, THE UNIT SHUTDOWN DURING TRANSPORT WHILE IN USE ON A PATIENT. THE UNIT WAS TESTED BY CUSTOMER'S BIOMED FOR A FEW DAYS. THE DISTRIBUTOR'S SERVICE ENGINEER CHECKED THE BATTERY CONTACTS, AND THE CUSTOMER'S BIOMED CHECKED THE BATTERIES. THE UNIT FUNCTIONED NORMALLY WAS SENT BACK TO USE. IN (B)(6) 2010, THE UNIT SHUTDOWN DURING TRANSPORT WHILE IN USE ON A PATIENT. FOLLOWING THE ADVICE OF THE DISTRIBUTOR'S SERVICE ENGINEER, THE CUSTOMER'S BIOMED REPLACED THE BATTERIES. IN (B)(6) 2010, THE UNIT SHUTDOWN TWICE WHILE IN USE ON A PATIENT. THE UNIT WAS TESTED AND RAN WITHOUT ISSUE FOR AN ADDITIONAL 2-3 DAYS. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK