BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAR DEVICE S7001, PMA # P990071

    MDR report key: 5665611 · Received May 19, 2016

    Report

    Report Number
    9612355-2016-00030
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    April 27, 2016
    Report Date
    April 28, 2016
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A STOCKERT J70 RF GENERATOR SYSTEM. THE REMOTE DISPLAYED BLACK AND ALSO DURING ABLATION THE STOP BUTTON ON THE REMOTE DID NOT WORK. SUBSEQUENTLY, THE STOP BUTTON ON THE STOCKERT J70 RF GENERATOR SYSTEM HAD TO BE PRESSED TO STOP THE ABLATION. THERE WAS NO UNWANTED ABLATION. THE ISSUE IMPROVED BY REBOOTING THE REMOTE BUT THE DISPLAY ISSUE OCCURRED OCCASIONALLY. WHEN THE MEMO KEY BUTTON WAS PRESSED, IT DISPLAYED OR DID NOT DISPLAY REPEATEDLY. ALTHOUGH THEY WERE STILL HAVING THE ISSUE, THE PROCEDURE WAS COMPLETED WITH USING THE SAME SYSTEM WITHOUT PATIENT CONSEQUENCE. THE DEVICE WAS EVALUATED AND POWER CABLE WAS DEFECTIVE. DEFECTIVE PART WAS REPLACED. ISSUE WAS RESOLVED. THE DEVICE WAS ALSO SUBJECTED TO PREVENTATIVE MAINTENANCE, SAFETY AND FUNCTIONAL TESTING AND ALL TESTS PASSED. THE DEVICE HISTORY RECORD (DHR) REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A STOCKERT J70 RF GENERATOR SYSTEM. THE REMOTE DISPLAYED BLACK AND ALSO DURING ABLATION THE STOP BUTTON ON THE REMOTE DID NOT WORK. SUBSEQUENTLY, THE STOP BUTTON ON THE STOCKERT J70 RF GENERATOR SYSTEM HAD TO BE PRESSED TO STOP THE ABLATION. THERE WAS NO UNWANTED ABLATION. THE ISSUE IMPROVED BY REBOOTING THE REMOTE BUT THE DISPLAY ISSUE OCCURRED OCCASIONALLY. WHEN THE MEMO KEY BUTTON WAS PRESSED, IT DISPLAYED OR DID NOT DISPLAY REPEATEDLY. ALTHOUGH THEY WERE STILL HAVING THE ISSUE, THE PROCEDURE WAS COMPLETED WITH USING THE SAME SYSTEM WITHOUT PATIENT CONSEQUENCE. THE INABILITY TO STOP RADIOFREQUENCY DURING ABLATION WAS ASSESSED AS A REPORTABLE MALFUNCTION AS IT CAN RESULT IN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323092 SIMILAR DEVICE S7001, PMA # P990071 LPB STOCKERT GMBH M-5463-320

    Patients

    Seq Age Sex Outcome Treatment
    1