BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 10526991 · Received September 14, 2020

    Report

    Report Number
    3005650109-2020-00036
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    April 14, 2020
    Report Date
    September 14, 2020
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05704819289612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE HAS BEEN REVIEWED RETROSPECTIVELY AS PART OF CAPA (B)(4), AND IT HAS BEEN DECIDED TO BE REPORTABLE. (BACKGROUND: A SOFTWARE ERROR HAS EVALUATED 21 CASES AS NON-POTENTIAL SAFETY EVENTS. THE RETROSPECTIVE REVIEW HAS EVALUATED 4 OF THE 21 AS REPORTABLE. THE SW ERROR HAS BEEN CORRECTED). IN THIS CASE, THERE HAS NOT BEEN REPORTED ANY SERIOUS INJURY (NO PERMANENT HARM, NO MEDICAL OR SURGICAL INTERVENTION). THE DEVICE MAY HAVE MALFUNCTIONED (NO SAMPLES AVAILABLE FOR TEST), AND IT CANNOT BE RULED OUT THAT IT, THEORETICALLY, CAN CAUSE, OR CONTRIBUTE TO A SERIOUS INJURY, SHOULD IT RECUR. THIS IS DUE TO IT'S A MEDIUM POWER DEVICE. THIS IS CONSIDERED A SINGLE INCIDENT, AND WILL BE INCLUDED IN REGULAR TRENDING. NO CORRECTIVE ACTIONS HAS BEEN INITIATED BASED ON THIS INDIVIDUAL EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE LOCAL HEARING AID DEALER:LT961 LOUD STATIC AND PULSATING BEEPS.HCP REPORTS HE SENT IN A LT961 HA FOR REPAIR WITH COMPLAINT THAT THE HA WAS DEAD. HE SAID IT WAS REPLACED W/ SETTINGS SAVED, BUT NOW THERE WAS STATIC. ISSUE PERSISTED WITH A NEW RECEIVER, AND CALIBRATING THE HA. HA WAS RESTORED, AND ISSUE SEEMED RESOLVED. I HAD HIM TRY TO SAVE PREVIOUS SETTINGS TO SEE IF THE ISSUE PERSISTED. INITIALLY IT RESOLVED THE ISSUE, BUT AFTER A FEW MINUTES, THE STATIC BEGAN. WE RESTORED THE HA AGAIN TO START IN A BRAND NEW FILE AND RESET TO INITIAL FIT (NOT SAVE THE PREVIOUS SETTINGS), BUT AFTER THE RESTORE, THERE WAS LOUD STATIC AND LOUD QUICK PULSATING BEEPING. I RECOMMENDED THAT HCP REMOVE HA FROM PT'S EAR DURING RESTORE, BUT HCP LEFT HA IN PT'S EAR. PT REMOVED THE HA DUE TO THE LOUD SOUND (STATIC/BEEPS) AFTER THE RESTORE, BUT HCP REPORTED NO HARM. BEEPING STOPPED AFTER OPENING BATTERY DOOR. STATIC CONTINUED IN NEW NOAH FILE AFTER RESET TO INITIAL FIT. I HAD HIM TAKE THE RECEIVER FROM THE RIGHT HA THAT WAS FUNCTIONING PROPERLY, PUT ON THE LEFT SIDE, BUT THE ISSUE PERSISTED ON THE LEFT SIDE. HCP SENDING IN FOR REPAIR. I RECOMMENDED THAT THE REPAIRED HEARING AID BE RETURNED W/ FACTORY SETTINGS. SENT QE FORM TO HCP. FLAGGED IN NAVISION. COMPLAINT CREATED. HAVE THE SYMPTOM(S) DISAPPEARED COMPLETELY? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995836 GN RESOUND LT961-DRW,RESOUND LINX3D 9 OSM GN HEARING A/S LT961-DRW,RESOUND LINX3D 9,GN RESOUND 05704819289612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention