ALGO Newborn Hearing Screener ALGO 5Recalls & reported problems
Natus Medical Incorporated · The ALGO 5 Newborn Hearing Screener is a mobile, cart-based, noninvasive instrument used to screen infants for hearing loss. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382830043939), received between Mar 16, 2022 and Jun 12, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Sparking” (2 reports).
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
- Sparking2
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2023Sparking; Sparking
ALGO 5 CART COLUMN WITH WIRING -CUSTOMER REPORTED THE ALGO 5 CART COLUMN WITH WIRING HAD PRESENTED INTERMITTENT LOSS OF POWER, AND THE SYSTEM WOULD NOT TURN ON. THE DEVICE WAS INSPECTED AND IT WAS NOTED THE POWER CORDS UNDER THE BASE HAS TORN INSULATION OF THE WIRING. THE CUSTOMER NOTED WHILE INSPECTING THE WIRING SHE EXPERIENCED A SHOCK FROM THE ALGO. IT WAS NOTED THAT THE WIRE APPEARED TO HAVE BEEN RUBBING AGAINST ONE OF THE WHEELS WHICH CREATED THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17113756 ↗MalfunctionMar 8, 2023Sparking; Sparking
ALGO 5 CART COLUMN WITH WIRING - WHEN INSTALLING THE PANEL PC TECHNICAL FOUND THAT HE WIGGLES THE CORD GOING INTO THE PANEL PC POWER SUPPLY IT CREATES SOMEWHAT OF A SPARK. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16502088 ↗MalfunctionMar 16, 2022Material Frayed; Material Frayed
CUSTOMER REPORTED ONE OF THE POWER CORDS IN THE COLUMN OF THE ALGO 5 NEWBORN HEARING SCREENER HAD DAMAGED INSULATION AND PROVIDED PHOTO. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13786749 ↗
Other Stimulator, Auditory, Evoked Response devices
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- GN Otometrics A/S ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US onlyNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 recall0 reports
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- AuDX PRO Device with touchscreen 100098-AUPPATH medical GmbH · Stimulator, Auditory, Evoked Response1 recall0 reports
- NIM-Eclipse® NCCPUMedtronic Xomed, Inc. · STIMULATOR, AUDITORY, EVOKED RESPONSE2 reports
- GN Otometrics A/S MADSEN AccuScreenNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 report
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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