BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS MEDICAL SYSTEMS -MULTI3500

    MDR report key: 1972763 · Received January 21, 2011

    Report

    Report Number
    MW5019146
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CONTRARY TO 21-CFR-820.170, THE MFR IS UNWILLING OR UNABLE TO PROVIDE INSTALLATION DOCUMENTATION. MFR HAS BEEN CONTACTED IN EXCESS OF 120 TIMES BY MAIL, EMAIL, FAX, AND USMAIL AND TO DATE HAS BEEN UNWILLING OR UNABLE TO SUPPLY INSTALLER INFO. CONTRARY TO 21-CFR-820.170, THE MFR IS UNWILLING OR UNABLE TO PROVIDE INSTALLATION OR INSTRUCTIONS ALLOWING THE OWNER OF THEIR MRI MACHINES, OR SERVICE PROVIDERS OF SAME THE ABILITY TO SEE IF THE SCANNER IS PERFORMING WITHIN OEM SPECIFICATION. SPECIFICATIONS ARE REMOVED FROM SYSTEM AND OWNERS, OPERATORS, AND OTHER SERVICE PROVIDERS ARE UNABLE AT ANY GIVEN TIME TO CONFIRM THIS MACHINE IS OPERATING WITHIN SAFE LIMITS. THIS EXPOSES THE PT TO EXTREME SAFETY HAZARDS AS THE OPERATOR HAS NO INDICATION THAT THE MACHINE MAY BE OPERATING OUT OF SPECIFICATION, OUT OF POWER LIMITS OR IF THE POWER LIMIT HARDWARE IS EVEN WORKING. CURRENT STANDARDS REQUIRE THE CUSTOMER, OWNER, SERVICE PROVIDER HAVE THE NECESSARY INSTALLATION ABILITY TO CHECK QUALITY ASSURANCE PROCEDURES TO INSURE THE MACHINE IS WORKING IN A SAFE AND PROPER MANNER. PHILIPS REMOVED THE ABILITY TO SEE IF THE QA IS PASSING IN SOFTWARE UPDATES FROM 2001; THUS FOR OVER 10 YRS, THE OEM HAS NOT COMPLIED WITH 21-CFR-820.170. THE MFR CONTINUES TO DELAY PROVIDING REQUIRED INSTALLATION TOOLS. PHILIPS MEDICAL SYSTEMS / ATTN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS -MULTI3500 MRI LNH PHILIPS MEDICAL SYSTEMS INTERA
    2 PHILIPS MEDICAL SYSTEMS -MULTI3500 MRI LNH PHILIPS MEDICAL SYSTEMS / ATTN: DREW QUEEN MRI ACHIEVA
    3 PHILIPS MEDICAL SYSTEMS -MULTI3500 MRI LNH PHILIPS MEDICAL SYSTEMS / ATTN: DREW QUEEN MRI NT
    4 PHILIPS MEDICAL SYSTEMS -MULTI3500 CT JAK PHILIPS MEDICAL SYSTEMS / ATTN: DREW QUEEN BRILLANCE

    Patients

    Seq Age Sex Outcome Treatment
    1