PALMTOP REVEL VENTILATOR 19260-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 435 adverse event reports that list this exact device (DI 00845873000029), received between Aug 18, 2015 and Oct 4, 2024 — classified as 3 deaths, 109 injuries, 323 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (330 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

Recent adverse event reports

The 25 most recent of 435 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT THE VENT MADE ODD NOISES AND FAILED TO DELIVER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372334 ↗
• InjuryMay 1, 2024Crack; Gas Output Problem; Crack; Gas Output Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT VENTILATOR WAS INOPERABLE, FLASHING WHEN IN USE AND PIGTAIL IS DAMAGED SHOWING THE WIRES. REVEL COMING IN FOR REPAIR/ 6YR/30K PM. CUSTOMER DECLINED PACKAGING. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220189 ↗
• MalfunctionApr 24, 2024No Display/Image; No Display/Image

  IT WAS REPORTED TO VYAIRE MEDICAL THAT UPON GOING TO START UP THE VENT IT BEGAN BEEPING AND VENT INOP LIGHT IS SEEING FLASHING RED ALONG WITH THE CONTROL LOCK, MANUAL BREATH, AND MANEUVERS BUTTONS ALL BEING LIT UP GREEN. THE VENT CYCLED ON TWICE WITH THE LED SCREEN LIGHTING UP FOR A SECOND BUT THEN SHUTTING OFF (GOING BLANK) IMMEDIATELY AFTER BOTH TIMES. NO PATIENT INVOLVEMENT, ISSUE FOUND DURING START-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169865 ↗
• MalfunctionApr 16, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR IS COMING IN DUE TO END USERS REPORTING LOSS OF POWER ON THE DISPLAY. UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NONE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116324 ↗
• MalfunctionApr 11, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WERE COMPLAINTS OF AN O2 LEAK. BIOMED INDICATES THEY HAVE THE O2 CONNECTED AT 50 PSI AND TURNS IT OFF THE PSI SLOW DECREASES. AFTER FOLLOWING UP ON THE ISSUE BIOMED INFORMED VYAIRE THAT THE RED MOUNTS FOR THE O2 BLENDER HAD SOMEHOW BECOME PARTIALLY LOOSE ON THE SIDE AWAY FROM THE BLENDER. THIS ALLOWED JUST A VERY SLIGHTLY IMPERFECT SEAL ALLOWING THE LEAK TO OCCUR BUT NOT AFFECTING O2 OUTPUTS IN THE CASE TESTING. ISSUE HAS BEEN RESOLVED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087266 ↗
• MalfunctionApr 4, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO VYAIRE MEDICAL TECH SUPPORT THAT A DEVICE WITH CONFIGURE RESET AND SERVICE 90 CODES (CODE A0801 FAILURE TO CALIBRATE). NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047612 ↗
• MalfunctionMar 26, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED TO VYAIRE THAT THE DEVICE HAD CONFIGURATION RESET AND MULTIPLE SCH SVC ALARMS. FURTHERMORE, THE HOURS ON THE DEVICE WERE RESET. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18983466 ↗
• MalfunctionMar 20, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CONFIGURATION RESET AND SCH SERVICE ALARMS APPEARED ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18945653 ↗
• MalfunctionMar 18, 2024Gradient Increase; Gradient Increase

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR IS GIVING THE HI O2 PRESS ALARM. THEY ONLY USE THE HIGH PRESSURE PORT WITH EITHER AN O2 TANK OR WALL PRESSURE. IT WAS CONFIRMED THE WALL PRESSURE AND IT'S AROUND 50 PSI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927317 ↗
• MalfunctionMar 6, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED TO VYAIRE MEDICAL THAT TEH REVEL VENTILATOR WILL NOT VENTILATE AND GIVES PT CIRCUIT FAULT ALARM. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847535 ↗
• MalfunctionFeb 2, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO VYAIRE MEDICAL THAT VENTILATOR INOPERABLE ALARM OCCURRED ON THE REVEL VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630336 ↗
• MalfunctionFeb 1, 2024Defective Component; Defective Component

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE REVEL VENTILATOR BLOWER IS NOT FUNCTIONING. AT THIS TIME, THERE WAS NO INFORMATION FOR PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627801 ↗
• MalfunctionJan 23, 2024Defective Component; Defective Component

  IT WAS REPORTED TO VYAIRE MEDICAL THAT SAFETY VALVE HIGH PRESSURE ALARM OCCURRED DURING USE ON A PATIENT ON THE REVEL VENTILATOR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18567720 ↗
• MalfunctionJan 19, 2024Overfill; Overfill

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DEVICE WAS AUTO-CYCLING DURING USE ON A PATIENT ON THE REVEL VENTILATOR. THE CUSTOMER CONFIRMED THERE IS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547712 ↗
• MalfunctionJan 18, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE REVEL VENTILATOR HAD AN INACCURATE VT. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539253 ↗
• MalfunctionJan 18, 2024Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT TEH REVEL VENTILATOR COMING IN DUE TO VENT INOP (VENTILATOR INOPERABLE) ALARM AND CYCLING POWER ON ITS OWN. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18538769 ↗
• MalfunctionJan 18, 2024Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE REVEL VENTILATOR COMING IN DUE TO VENT INOP (VENTILATOR INOPERABLE) ALARM. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536151 ↗
• MalfunctionJan 16, 2024Failure to Deliver; Improper Flow or Infusion; Failure to Deliver; Improper Flow or Infusion

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE REVEL VENTILATOR IS NOT DELIVERING VOLUMES WHILE ON PATIENT. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522993 ↗
• MalfunctionJan 3, 2024Tidal Volume Fluctuations; Tidal Volume Fluctuations

  IT WAS REPORTED TO VYAIRE MEDICAL THAT TIDAL VOLUME READING IS 200ML HIGHER THAN WHAT IS SET DURING PATIENT USE ON THE REVEL VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434997 ↗
• MalfunctionDec 18, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE REVEL, ENGLISH SERVICE REPAIR VENTILATOR MAIN LED HAS DAMAGED PIXELS. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345865 ↗
• MalfunctionDec 15, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT LOWER INTERFACE IS NOT WORKING ON THE REVEL VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340768 ↗
• MalfunctionDec 15, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE REVEL VENTILATOR O2 % IS INACCURATE. FURTHERMORE, THERE WAS NO INFORMATION FOR PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336110 ↗
• MalfunctionDec 4, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE REVEL VENTILATOR HAD SERVICE 93 ALARM OCCURRED. THE CUSTOMER CONFIRMED THAT INITIALLY, THE DEVICE HAVING NO ALARMS, BUT SHOWING LOW PIP (PEAK INSPIRATORY PRESSURE) ON SCREEN, BUT READING WAS FINE. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256464 ↗
• InjuryDec 4, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE REVEL VENTILATOR STOPPED TWICE ON TWO SEPARATE OCCASIONS WITH NO WARNING. PATIENT WAS HARMED DUE TO THE VENTILATOR STOPPING ABRUPTLY. FURTHERMORE, THE CUSTOMER INDICATED THEY DO NOT HAVE FURTHER INFORMATION ON SETTINGS OR THE SPECIFIC CIRCUMSTANCES OF THE OCCURRENCE.

  Patient problems: Insufficient Information

  MAUDE report 18256424 ↗
• MalfunctionDec 1, 2023Defective Component; Defective Component

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE REVEL VENTILATOR HAS A DEFECTIVE BLENDER. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248352 ↗