BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI-TECIII ASPIRATOR 110V,STND

    MDR report key: 9539701 · Received January 2, 2020

    Report

    Report Number
    1645337-2020-00078
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 6, 2019
    Report Date
    December 6, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    MUU
    UDI-DI
    00081317023364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS REPAIRED IN THE FIELD. ON OCTOBER 25, 2020, UNIT EVALUATION WAS COMPLETED. UNIT EVALUATION SUMMARY: DURING THE VISUAL EVALUATION OF THE SAMPLE, MINOR SCRATCHES ON THE UNIT WERE OBSERVED. PER SERVICE MANUAL, OPERATIONAL AND DIAGNOSTIC ANALYSIS, CONFIRMED FUSE ISSUE / POWER ENTRY MODULE ISSUE. REPLACED DAMAGED POWER ENTRY MODULE AND 2 MISSING FUSES AS IDENTIFIED IN THE INVESTIGATION TO ADDRESS THE REPORTED ISSUE. UNRELATED, REPLACED DAMAGED CASTER. THE TESTING OF THE DEVICE WAS COMPLETED PER SERVICE MANUAL. THE UNIT HAS PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR SERIAL NUMBER 04-0943-05, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. ON OCTOBER 26, 2020, MENTOR BECAME AWARE THAT SERIOUS INJURY WAS INCORRECTLY SELECTED UNDER FIELD H1 (TYPE OF REPORTABLE EVENT) UNDER THE PREVIOUS INITIAL SUBMISSION. IT HAS BEEN CORRECTED TO MALFUNCTION ON THIS REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V WAS CONTINUALLY BLOWING AND MELTING FUSES UPON USE. IT JUST STARTED HAPPENING. NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111 PSI-TECIII ASPIRATOR 110V,STND SYSTEM, SUCTION, LIPOPLASTY MUU MENTOR TEXAS PT-ASP-III-110 00081317023364

    Patients

    Seq Age Sex Outcome Treatment
    1