AtmosAir Velaris 633026Recalls & reported problems
Arjohuntleigh AB · AtmosAir Velaris Mattress - Standard - 860 x 1980 x 180 mm (34 x 78 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 05059441149927), received between May 26, 2023 and May 26, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem2
Patient problems
- Pressure Sore/Ulcer2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2023Deflation Problem; Deflation Problem
THE NURSE REPORTED THAT THE PATIENT'S PRESSURE INJURY STAGE IV WORSENED AND DOUBLED IN SIZE (FROM L: 3.92CM X W:1.95 CM TO L:6.39CM X W: 9.11 CM). ALLEGEDLY, THE TUBING RUNNING FROM THE PUMP INTO THE MATTRESS WAS PINCHED WHICH LED TO LOW AIR FLOW. THE PUMP DID ALARM INFORMING STAFF OF THE ISSUE.
Patient problems: Pressure Sore/Ulcer
MAUDE report 17008597 ↗InjuryMay 26, 2023Deflation Problem; Deflation Problem
THE NURSE REPORTED THAT THE PATIENT'S PRESSURE INJURY STAGE IV WORSENED AND DOUBLED IN SIZE (FROM L: 3.92CM X W:1.95 CM TO L:6.39CM X W: 9.11 CM). ALLEGEDLY, THE TUBING RUNNING FROM THE PUMP INTO THE MATTRESS WAS PINCHED WHICH LED TO LOW AIR FLOW. THE PUMP DID ALARM INFORMING STAFF OF THE ISSUE.
Patient problems: Pressure Sore/Ulcer
MAUDE report 17008596 ↗
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.
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