AtmosAir Velaris 633028Recalls & reported problems
Arjohuntleigh AB · AtmosAir Velaris Mattress - Standard - 880 x 2140 x 180 mm (35 x 84 x 7 in) - Top Cover Premium · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05059441149941), received between Sep 25, 2024 and Sep 25, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Dent in Material” (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.
Reports received per month
Most reported problems
Device problems
- Dent in Material2
Patient problems
- Tissue Breakdown2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2024Dent in Material; Dent in Material
IT WAS REPORTED THAT THE PATIENT SUSTAINED THE DTPI (DEEP TISSUE PRESSURE INJURY) ON THE LEFT BUTTOCK/COCCYX AREA WHEN USING THE VELARIS MATTRESS. THE MATTRESS WAS NOTED TO BE SUCKED IN THE MIDDLE AND THE MIDDLE CELL WAS NOTED TO BE DEFLATED. CONNECTING THE MATTRESS TO THE PUMP DID NOT CHANGE THE MATTRESS STATUS.
Patient problems: Tissue Breakdown
MAUDE report 20301014 ↗InjurySep 25, 2024Dent in Material; Dent in Material
IT WAS REPORTED THAT THE PATIENT SUSTAINED THE DTPI (DEEP TISSUE PRESSURE INJURY) ON THE LEFT BUTTOCK/COCCYX AREA WHEN USING THE VELARIS MATTRESS. THE MATTRESS WAS NOTED TO BE SUCKED IN THE MIDDLE AND THE MIDDLE CELL WAS NOTED TO BE DEFLATED. CONNECTING THE MATTRESS TO THE PUMP DID NOT CHANGE THE MATTRESS STATUS.
Patient problems: Tissue Breakdown
MAUDE report 20301006 ↗
Other Mattress, Air Flotation, Alternating Pressure devices
- Medline MDT24A20Medline Industries, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE267 reports
- Medline MDT24A10Medline Industries, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE118 reports
- Guardian GS-2.5-CTurncare Inc · Mattress, Air Flotation, Alternating Pressure2 recalls15 reports
- IsoAir 2941Stryker Corporation · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE1 recall1 report
- Arise 1000 EX AREXLAL-CUJoerns Healthcare, LLC · Mattress, Air Flotation, Alternating Pressure1 recall0 reports
- Medline MDT24SUPRAAPLMedline Industries, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE42 reports
- Medline MDT24SUPRADPSMedline Industries, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE40 reports
- Synergy® Surface P6881Hill-Rom, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE28 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.
How reports and recalls are matched · Editorial policy · Report an error on this page