BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS HI

    MDR report key: 10101086 · Received May 29, 2020

    Report

    Report Number
    3002466018-2020-31210
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 23, 2020
    Report Date
    August 15, 2022
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS COULD NOT PERFORM A DETAILED TECHNICAL INVESTIGATION OF THE REPORTED COMPONENT AND COMPLAINT EVENT BECAUSE THE BROKEN WATER HOSE HAS NOT BEEN RETURNED FOR INVESTIGATION, A DETAILED ROOT CAUSE ANALYSIS WAS NOT POSSIBLE. WITHIN TECHNICAL INVESTIGATIONS OF SIMILAR COMPLAINTS, IT HAS BEEN FOUND THAT THE WATER HOSE (PART NUMBER 10306180) HAS BEEN DESIGNED SUFFICIENTLY ROBUST FOR ITS PURPOSE. NEVERTHELESS, IN CASE A HOSE BECOMES LEAKY, A SPARE PART KIT IS AVAILABLE (PART NUMBER 5861757). THE SYSTEM HAS BEEN REPAIRED BY REPLACEMENT OF THE BROKEN WATER HOSE. THE SPARE PART CONSUMPTION OF THE RELATED WATER HOSE HAS BEEN CHECKED AND WAS FOUND TO BE AT A VERY RATE. NO GENERAL DESIGN ISSUE HAS BEEN IDENTIFIED, THEREFORE NO REMEDIAL ACTION DEEMED NECESSARY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). SIEMENS HAS INITIATED A TECHNICAL INVESTIGATION OF THE EVENT. THE ROOT CAUSE OF THIS EVENT WAS THE BROKEN DI WATER HOSE. THE WATER HOSE WAS REPAIRED BY AN IN-HOUSE ENGINEER THE MORNING OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS BY THE CUSTOMER THAT THE DEIONIZED (DI) WATER PUMP STAND HOSE DISCONNECTED FROM THE FITTING AND A LARGE AMOUNT OF WATER CAME OUT RESULTING IN THE FLOOR BECOMING WET. HOSPITAL PERSONNEL WERE PRESENT AT THE TIME OF THE EVENT AND REACTED IMMEDIATELY BY PRESSING THE EMERGENCY STOP BUTTON. THE EVENT OCCURRED DURING DAILY QUALITY ASSURANCE MEASUREMENTS. THERE WAS NO PATIENT MISTREATMENT OR USER INJURY ASSOCIATED WITH THIS EVENT. IN A WORST-CASE SCENARIO, THE WATER SPILL ON THE FLOOR COULD RESULT IN A SLIPPING INJURY OR MEDIUM SEVERITY. A FALL OF THIS KIND MAY REQUIRE MEDICAL INTERVENTION. THIS REPORT IS BEING SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564902 PRIMUS HI ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS HEALTHCARE GMBH 4504200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown