BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS+

    MDR report key: 4170132 · Received October 14, 2014

    Report

    Report Number
    1217157-2014-00158
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K091216
    Removal / Correction Number
    1217157-09-22-2014-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) OF THESE POWER SUPPLIES HAS IDENTIFIED TWO ROOT CAUSES FOR THE DAMAGED POWER SUPPLY ADAPTORS. 1. THE INCORRECT TORQUE SETTING WAS SELECTED BY THE PRODUCTION OPERATOR FOR THE SCREWS USED TO SECURE THE POWER SUPPLY ADAPTOR HOUSINGS TOGETHER. 2. MINERAL OIL WAS FOUND ON THE SCREWS USED TO SECURE THE HOUSINGS TOGETHER. THE OIL IS USED DURING THE MACHINING PROCESS DURING THE PRODUCTION OF THE SCREWS AND WAS NOT REMOVED BY THE SCREW SUPPLIER. THESE TWO ROOT CAUSES RESULTED IN A COMBINATION OF MECHANICAL AND CHEMICAL STRESS WHICH LED TO THE CRACKING OF THE SCREW PILLARS INSIDE THE HOUSING TOP OF THE POWER SUPPLY ADAPTOR. SIEMENS ISSUED AN URGENT FIELD SAFETY NOTICE (31983 REV. A) TO NOTIFY ALL AFFECTED SIEMENS CUSTOMERS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY RECEIVED BROKEN POWER SUPPLY. CUSTOMER ALSO REPORTED THAT THEY DETECTED BROKEN POWER SUPPLY BEFORE INSTALLATION AND ANY USE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649549 CLINITEK STATUS+ CT STATUS+ JIL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1