King Mask 1022Recalls & reported problems
Ambu A/S · Disposable anesthesia face mask · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612649184777), received between Feb 14, 2019 and Feb 14, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2019Material Deformation
DURING RESUSCITATION CPAP MASK WENT COMPLETELY FLAT, MAKING IT EXTREMELY DIFFICULT TO MAINTAIN A SEAL FOR INFANT. PRIOR TO DELIVERY, MASK WAS CHECKED BY 3 NURSES INCLUDING THIS RN AND THE NICU RN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8343158 ↗
Other MASK, GAS, ANESTHETIC devices
- Ventlab BT4040Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT2048Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4018Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4013Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4019Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4022Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4015Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4024Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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