BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 788921 · Received May 24, 2006

    Report

    Report Number
    9616026-2006-00201
    Event Type
    Other
    Date Received
    May 24, 2006
    Manufacturer
    *
    Product Code
    MQS
    PMA / PMN Number
    k041005
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY WAS REPORTED. AN INVESTIGATION TO COLLECT ADD'L CLINICAL DATA REMAINS ONGOING. THE FIELD TECH THAT INVESTIGATED THE INCIDENT WAS NOT ABLE TO DUPLICATE THE REPORTED CONDITION. THE TECH FOUND IN DOWNLOADED DATA FILES THAT NO HEPARIN SYRINGE RATE WAS SET UNTIL AFTER APPROX 1 HR INTO TREATMENT WITH MULTIPLE SYRINGE PUMP ALARMS. THE SYRINGE PUMP WAS CALIBRATED AND VERIFIED. RAN PRIME SELF-TEST AND SIMULATED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * MQS * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *