Ambu aView™ 2 Advance 405011000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05707480145089), received between Apr 4, 2024 and Jun 12, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

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 16, 2026.

Recalls naming this device

1. Dec 5, 2023Open, Classified

   Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.

   Z-0714-2024 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 21, 2023Open, Classified

   Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames

   Z-2628-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2024Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  ACCORDING TO THE INFORMATION FROM THE CUSTOMER, THE HOUSING OF THE MONITOR HAS BULGED. THEY REPORTED THAT THE BATTERY HAS INFLATED AND BURST THE MONITOR. PICTURES WERE DELIVERED FOR THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522066 ↗
• MalfunctionJun 12, 2024Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  ACCORDING TO THE INFORMATION FROM THE CUSTOMER, THE HOUSING OF THE MONITOR HAS BULGED. THEY REPORTED THAT THE BATTERY HAS INFLATED AND BURST THE MONITOR. PICTURES WERE DELIVERED FOR THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518071 ↗
• MalfunctionApr 4, 2024Failure to Power Up; Failure to Power Up

  THE USER REPORTED THAT THE MONITOR WAS NOT RESPONDING AND HAVING ISSUE BOOTING UP WHILST TRYING TO INTUBATE A PATIENT. ANOTHER MONITOR WAS USED AND THE PATIENT WAS INTUBATED SUCCESSFULLY. THE USER HAS REPORTED THAT THE MONITOR HAS WORKED AGAIN AFTER A HARD RESET HOWEVER THEY HAVE NOTICED BOOTING AND SHUTTING DOWN ISSUES WITH THIS MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048038 ↗
• MalfunctionApr 4, 2024Failure to Power Up; Failure to Power Up

  THE USER REPORTED THAT THE MONITOR WAS NOT RESPONDING AND HAVING ISSUE BOOTING UP WHILST TRYING TO INTUBATE A PATIENT. ANOTHER MONITOR WAS USED AND THE PATIENT WAS INTUBATED SUCCESSFULLY. THE USER HAS REPORTED THAT THE MONITOR HAS WORKED AGAIN AFTER A HARD RESET HOWEVER THEY HAVE NOTICED BOOTING AND SHUTTING DOWN ISSUES WITH THIS MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039919 ↗