BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINLAB IMRI OR POWER MANAGEMENT

    MDR report key: 1624771 · Received March 5, 2010

    Report

    Report Number
    8043933-2010-00003
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    February 6, 2010
    Report Date
    February 6, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER MANAGEMENT CONFIGURATION IS NOT A MEDICAL DEVICE BUT CONTAINS PROJECT SPECIFIC 3RD PARTY STANDARD PRODUCTS SOLD BY (B)(4) FOR THE POWER SUPPLY OF THE (B)(6). ACCORDING TO THE HOSPITAL, THE SURGERY WAS FINALIZED WITHOUT ANY IMMEDIATE ADVERSE CLINICAL OUTCOME FOR THE PATIENT. THE TUMOR RESECTION WAS FAR ADVANCED AND USER DECIDED NOT TO CONTINUE RESECTION. BRAINLAB INVESTIGATION HAS SHOWN THAT 2 OF THE BATTERIES INSIDE THE UNINTERRUPTIBLE POWER SUPPLY PROVIDED WITH THE BRAINLAB IMRI OR POWER MANAGEMENT WERE DEFECTIVE. THE USER HAD CONNECTED OTHER HOSPITAL DEVICES USED FOR THE SURGERY TO NON-PERMANENT POWER OUTLETS. BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS: POTENTIALLY AFFECTED (B)(6 CUSTOMERS RECEIVE A PRODUCT NOTIFICATION INFORMATION. BRAINLAB WILL VISIT ALL SITES WHERE A UPS IS PART OF THE BRAINLAB IMRI OR POWER MANAGEMENT TO TEST IF THE UPS STILL PROVIDES SUFFICIENT POWER TO BRIDGE THE SHORT PERIOD OF TIME UNTIL THE HOSPITAL'S GENERATOR IS ACTIVE. BRAINLAB WILL VISIT ALL POTENTIALLY AFFECTED (B)(6 IMRI SITES TO ASSESS IF THE POWER SUPPLY OF THE OR LIGHTS IS CONFIGURED REDUNDANTLY WITH A SEPARATE POWER LINE.

    Description of Event or Problem · 1

    DURING A BRAIN SURGERY INSIDE A (B)(6) OPERATING ROOM, THE POWER OF THE OR LIGHTS, MICROSCOPE AND OTHER HOSPITAL DEVICES WAS INTERRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINLAB IMRI OR POWER MANAGEMENT OR POWER MANAGEMENT HAW BRAINLAB AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other