PrevaMatt 253-3680Recalls & reported problems
Joerns Healthcare, LLC · PROCAIR VR 36X80 · Class 1
Data updated Oct 16, 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 00810055883912), received between Sep 4, 2025 and Sep 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT COMPLAINT FROM (B)(6) WITH PROCAIR VR FOAM MATTRESS ON TOP STATING THIS- "PATIENT STATES THAT WITH HIS BACK PROBLEMS THAT BAR IS CAUSING HIM DISCOMFORT, AND HE IS UNABLE TO SLEEP WELL." (B)(6) REQUESTED TO PROCESS A REPLACEMENT ORDER TO REPLACE THE FAULTY PROCAIR VR MATTRESS WITH A TXCAIR PLUS LAL MATTRESS SYSTEM, THAT WAS JUST PURCHASED ON (B)(6) 2025." COMPLAINT #(B)(4) AND RA #(B)(4) WERE ENTERED INTO OUR FACILITY TO HAVE THE MATTRESS RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE UNITS HAVE NOT BEEN RETURNED.
Patient problems: Discomfort
MAUDE report 22974726 ↗
Other Mattress, Flotation Therapy, Non-Powered devices
- IsoTour 2874Stryker Corporation · MATTRESS, FLOTATION THERAPY, NON-POWERED4 reports
- BED MAT-5X28X58-CRIB CFT FOAM-CAL129-PC BM-52858-CRCF129-PCCurbell Medical Products, Inc. · Mattress, Flotation Therapy, Non-Powered3 reports
- DRIVEMEDICAL 6500-DE-2-FBDrive Devilbiss Healthcare · MATTRESS, FLOTATION THERAPY, NON-POWERED1 report
- DRIVEMEDICAL SSP216DDA-ELRDrive Devilbiss Healthcare · MATTRESS, FLOTATION THERAPY, NON-POWERED1 report
- Drive 15970-4280Drive Devilbiss Healthcare · MATTRESS, FLOTATION THERAPY, NON-POWERED1 report
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 16, 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