BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 8384462 · Received March 2, 2019

    Report

    Report Number
    3003477173-2019-00003
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Date of Event
    February 5, 2019
    Report Date
    March 1, 2019
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP ARRIVED WITH SIGNS OF NORMAL WEAR AND TEAR. THERE WAS NO INDICATION OF MODIFICATION OR MISUSE OF THE DEVICE. THE CLICKING UPON DECOMPRESSION WAS CONFIRMED AS REPORTED. THE CLAMSHELL WAS OPENED TO GET ACCESS TO THE SPRING SUBASSEMBLY HOLE. ALTHOUGH THE MICROMETER HAD TO BE HELD AT A SLIGHT ANGLE, THE MEASUREMENTS WERE CONSISTENT (11.12, 11.18, 11.29 AND 11.17) AND ALL WELL BELOW THE CURRENT SPECIFICATION OF 12.4 +/- 0.1 MM. THIS ISSUE WAS ADDRESSED IN LATE 2015. REFERENCE ENGINEERING EVALUATION REPORT # (B)(4). THE CORRECTION FOR THE CLICKING WAS TO WIDEN THE SPRING SUBASSEMBLY HOLE AND REV THE DRAWING TO INDICATE THIS DIMENSION AS CRITICAL. REFER TO CHANGE ORDER (B)(4). THIS PUMP WAS BUILT PRIOR TO IMPLEMENTATION OF THE NEW DRAWING.

    Description of Event or Problem · 1

    THIS RESQPUMP WAS IDENTIFIED DURING THE DAILY CHECK OF THE DEVICE AND NOT DURING PATIENT CARE. THE RESQPUMP IS MAKING A "CLICKING" NOISE WHEN COMPRESSING AND DECOMPRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177466 RESQPUMP PIZ

    Patients

    Seq Age Sex Outcome Treatment
    1