GN Otometrics A/S MADSEN AccuScreenRecalls & reported problems
Natus Medical Denmark ApS · Class 2
All models of GN Otometrics A/S (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05713315003974), received between Oct 26, 2022 and Oct 26, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
Other Stimulator, Auditory, Evoked Response devices
- GN Otometrics A/S ICS Chartr EP 200 Insert, Bone 2 Ch, US onlyNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 recall0 reports
- GN Otometrics A/S ICS Chartr EP 200 Insert 2 Ch, US OnlyNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 recall0 reports
- GN Otometrics A/S ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US onlyNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 recall0 reports
- 1077 DPOAE/TEOAE PROBE 8-69-41100PATH medical GmbH · Stimulator, Auditory, Evoked Response1 recall0 reports
- AuDX PRO Device with touchscreen 100098-AUPPATH medical GmbH · Stimulator, Auditory, Evoked Response1 recall0 reports
- ALGO Newborn Hearing Screener ALGO 5Natus Medical Incorporated · Stimulator, Auditory, Evoked Response3 reports
- NIM-Eclipse® NCCPUMedtronic Xomed, Inc. · STIMULATOR, AUDITORY, EVOKED RESPONSE2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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