BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNERVATOR

    MDR report key: 824229 · Received January 23, 2007

    Report

    Report Number
    9611451-2007-00009
    Event Type
    Malfunction
    Date Received
    January 23, 2007
    Date of Event
    December 20, 2006
    Report Date
    January 23, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BXN
    PMA / PMN Number
    K882438
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FROM HOSPITAL WAS RECEIVED BY PHONE CALL TO OUR COMPANY OFFICE ON 22 DEC 06. FOLLOW-UP CONTACT BY US OFFICE WITH HOSPITAL WAS ATTEMPTED TUESDAY DEC 26, LEFT MESSAGE ON ANSWERPHONE. RETURN VOICE MAIL RECEIVED TUES. DEC 26 INDICATING NS252 HAD BEEN SENT TO A 3RD PARTY FOR FURTHER INVESTIGATION. FOLLOW-UP CONTACT ATTEMPTED AGAIN BY OUR COMPANY ON MONDAY JAN 08 2007-RETURN VOICEMAIL FROM THE REPORTER, INDICATED THAT FURTHER FOLLOW-UP ON THE INCIDENT SHOULD BE CONDUCTED WITH BIOMEDICAL ENGINEERING. COMPANY OFFICE CONTACTED FROM THE REPORTER, IT WAS IDENTIFIED THAT A CAUTERIZER WAS IN USE AND ACTIVE WHEN THE NS252 WAS APPLIED. A LIST OF QUESTIONS WAS SENT TO THE HOSPITAL ON OR AROUND THE 17 JAN 07. AS OF 22 JAN 07 NO REPLY RECEIVED. WE ARE AWAITING FURTHER RESPONSE FROM THE HOSPITAL. NOTE: NS252 IS REUSABLE DEVICE, ELECTRODE PADS ARE SINGLE USE.

    Description of Event or Problem · 1

    FISHER & PAYKEL HEALTHCARE LTD NERVE STIMULATOR (NS252) AND ELECTRODE PAD USED DURING A SURGICAL PROCEDURE. FOLLOWING THE 4 TO 5 HR PROCEDURE (NEPHRECTOMY) THE PAD WAS REMOVED FROM THE MALE PT'S FACE. THE OUTSIDE OF THE PAD HAD A 'BURN' MARK, AND THE PT'S SKIN SHOWED A SLIGHT RED MARK WHICH DISAPPEARED AFTER 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNERVATOR NERVE STIMULATOR BXN FISHER & PAYKEL HEALTHCARE, LTD. NS252 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR DIATHERMY WAS USED DURING THE PROCEDURE.