BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTAVUS BERA 1 KANAL GERÄT

    MDR report key: 12632372 · Received October 14, 2021

    Report

    Report Number
    9612197-2021-00013
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    October 11, 2021
    Report Date
    February 4, 2021
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP 001 REF NATUS COMPLAINT#(B)(4). THE AFFECTED PART WAS RETURNED FOR EVALUATION AND DOC-058401 REV A COMPLAINT INVESTIGATION REPORT WAS COMPLETED. INVESTIGATION METHOD - REPRODUCE THE ISSUE IN HOUSE AND MEASURE THE OUTPUT LEVEL OF THE HEADSET USING STIMULUS LEVEL 100 DBHL AND 80 DBHL THEN ANALYZE THE DATA TO SEE IF IT WOULD REACH A HARMFUL LEVEL. ALSO PERFORM A ESD TEST ON THE DEVICE ACCORDING TO THE STANDARD IEC 60645-5 UNDER SUPERVISION OF THE HARDWARE TEAM. THE INVESTIGATING TEAM DID NOT FIND ANY ISSUES WITH THE DEVICE ITSELF, BASED ON THE INVESTIGATION RESULTS. THE ACUSTICAL AND ESD MEASUREMENTS DID NOT SHOW ANY RESULTS THAT WOULD BE HARMFUL FOR THE USER. RECOMMENDED ACTIONS: RETURN THE DEVICE BACK TO THE CUSTOMER AND MAYBE RECOMMEND THE CUSTOMER TO ACQUIRE A NEWER DEVICE, SINCE THE OCTAVUS DEVICE HAS MEET ITS END OF LIFE. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. NO FURTHER ACTIONS REQUIRED. NO FAULT FOUND. COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    DURING THE EXAMINATION WITH PART 18011001 ((B)(6)), A SUDDEN NOISE WAS SAID TO HAVE HIGHLIGHTED SEVERE TINNITUS AND HEARING LOSS ON THE RIGHT SIDE IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). PROCEDURE THAT WAS CARRIED OUT AT THE TIME OF THE EVENT WAS BRAINSTEM AUDIOMETRY. THE PATIENT CAME WITH THE FOLLOWING COMPLAINTS: TINNITUS AND HEARING LOSS ON THE LEFT. DURING THE EXAMINATION WITH THE OCTAVUS ABR, A SUDDEN NOISE WAS SAID TO HAVE HIGHLIGHTED SEVERE TINNITUS AND HEARING LOSS ON THE RIGHT SIDE IN THE PATIENT. A HEARING TEST WAS THEN CARRIED OUT WHICH WAS, HOWEVER, INCONSPICUOUS AND SYMMETRICAL. HOWEVER, THE PATIENT WAS IMMEDIATELY TREATED BY THE DOCTOR AND WAS ABLE TO LEAVE THE PRACTICE. SHE DID NOT DETECT ANY DAMAGE TO THE PATIENT DURING HER EXAMINATION. THE PATIENT CLAIMS TO HAVE BEEN DAMAGED, THIS COULD NOT BE DETECTED BY THE DOCTOR. A PICTURE WAS PROVIDED OF THE DEFECTIVE DEVICE. ADDITIONAL QUESTIONS ANSWERED BY THE CUSTOMER. WAS THE SOUND MORE THAN 80DB? THE DEVICE WAS SET TO 70DB, THE PATIENT CLAIMS IT WAS LOUDER THAN THAT. DID THE NOISE OCCUR INDEPENDENTLY OF THE EXAMINATION? NO. IS THERE A CLAIM THAT THE DEVICE MALFUNCTIONED? ONLY BY THE PATIENT, THE DOCTOR SAYS IT WORKS FINE. HOW WAS THE PATIENT ON LEAVING THE EXAMINATION? HE WAS GIVEN MEDICAL ATTENTION, NO DAMAGE COULD BE DETECTED, BUT HE COMPLAINS OF HEARING LOSS. A DHR REVIEW IS NOT REQUIRED, AS THE DEVICE WAS IN SERVICE FOR MORE THAN TWO YEARS. INSTALLED DATE 10/6/2017. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE FOUND. UNIQUE IDENTIFIER (UDI) NUMBER NOT DOCUMENTED AS NOT APPLICABLE - DEVICE END OF LIFE PRE UDI REQUIREMENT. ALL COMPONENTS OF THE DEVICE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING THE EXAMINATION WITH PART 18011001 (OCTAVUS BERA 1 KANAL GERÄT), A SUDDEN NOISE WAS SAID TO HAVE HIGHLIGHTED SEVERE TINNITUS AND HEARING LOSS ON THE RIGHT SIDE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533165 OCTAVUS BERA 1 KANAL GERÄT OCTAVUS BERA 1 KANAL GERÄT EWO NATUS MEDICAL DENMARK APS 18011001

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other