BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYPUMP

    MDR report key: 4081132 · Received August 29, 2014

    Report

    Report Number
    2026095-2014-00167
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    July 11, 2014
    Report Date
    August 1, 2014
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE IN THIS INCIDENT WAS NOT AVAILABLE FOR RETURN. AS A LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CANNOT BE CONDUCTED. RESULTS: AS A DEVICE WAS NOT AVAILABLE FOR AN EVAL, NO METHODS WERE PERFORMED THEREFORE, RESULTS CANNOT BE OBTAINED. CONCLUSIONS: AT THIS TIME THE INCIDENT IS UNDER INVESTIGATION AND WE ARE PENDING THE RECEIPT OF ADD'L INFO. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    FILL VOLUME: UNK - ANP. FLOW RATE: UNK - ANP. PROCEDURE: UNK - ANP. CATHPLACE: UNK - ANP. (PLEASE REFERENCE 2026095-2014-00166/14-00651 A). REPORT 2 OF 2. INCIDENT #2: ON (B)(6) 2014, AN INTERNATIONAL CUSTOMER REPORTED THAT THERE WERE TWO INCIDENTS IN REGARDS TO AN ON-DEMAND PCA BUTTON THAT, "STAYED DOWN, DID NOT COME BACK UP". PTS EXPERIENCED INTOXICATION OF ANESTHESIA. ADD'L INFO FOR THIS INCIDENT HAS BEEN REQUESTED FROM THE CUSTOMER, BUT AT THIS TIME IS NOT AVAILABLE. ANP: ASKED NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527609 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DRUG: UNK