THERAKAIR VISIO 413412Recalls & reported problems
Arjohuntleigh AB · Alternating Pressure Surface Pump - Therakair Visio · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055982784139), received between Mar 27, 2025 and Mar 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sparking” (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. 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
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2025Sparking; Sparking
ARJO BECAME AWARE OF THE EVENT INVOLVING THERAKAIR VISIO PUMP. THE CUSTOMER INFORMED THAT THE POWER CORD WAS DAMAGED AND THE HUGE SPARK WAS OBSERVED. THE ARJO SERVICE TECHNICIAN INSPECTED THE DEVICE AND FOUND THAT THE CABLE WAS CUT AND THE INTERNAL WIRES WERE EXPOSED. THE PHOTOGRAPHIC EVIDENCE PROVIDED CONFIRMS MALFUNCTION AND SHOWS BURNING MARKS ON THE CABLE. THE FAULTY PART WAS REPLACED. THE MATTRESS WAS USED FOR PATIENT TREATMENT WHEN THE MALFUNCTION OCCURRED. NO INJURY WAS CLAIMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21705370 ↗
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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