GN Otometrics A/SRecalls & reported problems across all models

We found 6 models of GN Otometrics A/S by Natus Medical Denmark ApS in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2022 and Oct 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Incompatible” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GN Otometrics A/S recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 28, 2019Terminated

   There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.

   Z-0170-2020 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

Most reported GN Otometrics A/S problems

GN Otometrics A/S models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GN Otometrics A/S ICS Chartr EP 200 Insert 2 Ch, US Only

  Stimulator, Auditory, Evoked Response
  1 recall0 reports
• GN Otometrics A/S ICS Chartr EP 200 Insert, Bone 2 Ch, US only

  Stimulator, Auditory, Evoked Response
  1 recall0 reports
• GN Otometrics A/S ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only

  Stimulator, Auditory, Evoked Response
  1 recall0 reports
• GN Otometrics A/S MADSEN AccuScreen

  Stimulator, Auditory, Evoked Response
  1 report
• GN Otometrics A/S AURICAL

  Audiometer
  1 report
• GN Otometrics A/S Aurical FreeFit, Complete Solution

  Calibrator, Hearing Aid / Earphone And Analysis Systems
  1 report

Recent GN Otometrics A/S adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PART 8-04-13932 NATUS MEDICAL ACCUSCREEN ABR/DP TYPE 1077 - FALSE SCREENING RESULTS. REPORTED INCIDENT IN WHICH FALSE NEGATIVE SCREENING RESULTS WERE RECEIVED FROM TESTING AN INFANT WHO, UPON FURTHER INVESTIGATION, WAS IN FACT FOUND TO HAVE A HEARING IMPEDIMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672185 ↗
• MalfunctionMar 17, 2022Component Incompatible; Melted; Component Incompatible

  AURICAL CAN'T TURN ON - OTOAIR MELTED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791961 ↗
• MalfunctionMar 16, 2022Electrical /Electronic Property Problem; Electrostatic Discharge; Electrostatic Discharge

  CALLER REPORTS THEY FELT A STATIC SHOCK FROM THE DISPENSER MONITOR HEADSET AND NOW THE TALK FORWARD PORTION OF THE HEADSET IS NOT WORKING. THEY TRIED A KNOWN WORKING HEADSET IN THIS BOOTH, AND IT DOES NOT WORK IN THIS BOOTH, ONLY THE AUDIO WORKS ON THE HEADSET, NOT THE MICROPHONE PART. BOTH HEADSETS WORK FULLY IN THE OTHER BOOTH. THE CALLER BELIEVES THAT THE AURICAL ITSELF GOT PHYSICALLY DAMAGED WHEN THEY FELT THE STATIC SHOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13787420 ↗