Omron CompAir Compressor Nebulizer NE-C801Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00073796458010), received between Jan 21, 2021 and Feb 15, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Infusion or Flow 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE CONSUMER CALLED ON 1/18/2023 AND STATED THAT ON (B)(6) 2022 THE CONSUMER'S EX-HUSBAND DROVE HER TO THE HOSPITAL FOR BREATHING TREATMENT DUE TO HER DIFFICULTY BREATHING. SHE RECEIVED A PRESCRIPTION FOR MEDICATION (ALBUTEROL) AND A NEBULIZER. ON (B)(6) SHE RECEIVED THE UNIT AND USED IT 2-3 TIMES AT 7AM OR 8AM, 2PM, 7PM, THEN AT 11:30PM. DURING THE LAST TIME SHE TRIED TO DO A TREATMENT, HER UNIT WOULD NOT WORK. THE CONSUMER'S EX-HUSBAND TRIED TO HELP GET THE NEBULIZER TO WORK, AND WHEN HE COULDN'T, HE CALLED AN AMBULANCE FOR HER SINCE SHE COULD NOT BREATHE. SHE CLAIMEED THAT SHE TEMPORARILY DIED ON THE WAY TO THE HOSPITAL AND WAS REVIVED. SHE WAS HOSPITALIZED 4 DAYS. FOLLOW-UP CALLS WERE MADE TO THE CONSUMER ON 1/18/2023, 1/20/2023, AND 1/23/2023 WITH NO RESPONSE. THE CONSUMER RESPONDED TO A FOLLOW-UP CALL ON 2/14/2023. SHE STATED THAT SHE WAS 52 YEARS OLD. SHE TOOK TREATMENTS BECAUSE SHE HAD ALLERGY INDUCED ASTHMA AND HAD AN INHALER ON HAND. THE MEDICATION SHE TOOK WAS ALBUTEROL WITH A DILUTION RATIO OF 0.083%. SHE STATED DID NOT CLEAN THE UNIT SINCE SHE HAD IT FOR A DAY AND A HALF. SHE WOULD RINSE THE UNIT OUT AND LET IT AIR DRY BETWEEN USES. SHE STATED SHE DID ONE TREATMENT AT

  Patient problems: Dyspnea

  MAUDE report 16383477 ↗
• InjuryFeb 14, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE CONSUMER CALLED ON (B)(6) 2023 AND STATED THAT ON (B)(6) 2022, THE CONSUMER'S EX-HUSBAND DROVE HER TO THE HOSPITAL FOR BREATHING TREATMENT DUE TO HER DIFFICULTY BREATHING. SHE RECEIVED A PRESCRIPTION FOR MEDICATION (ALBUTEROL) AND A NEBULIZER. ON (B)(6) 2022, SHE RECEIVED THE UNIT AND USED IT 2-3 TIMES AT 7AM OR 8AM, 2PM, 7PM, THEN AT 11:30PM. DURING THE LAST TIME SHE TRIED TO DO A TREATMENT, HER UNIT WOULD NOT WORK. THE CONSUMER'S EX-HUSBAND TRIED TO HELP GET THE NEBULIZER TO WORK, AND WHEN HE COULDN'T, HE CALLED AN AMBULANCE FOR HER SINCE SHE COULD NOT BREATHE. SHE CLAIMED THAT SHE TEMPORARILY DIED ON THE WAY TO THE HOSPITAL AND WAS REVIVED. SHE WAS HOSPITALIZED 4 DAYS. FOLLOW-UP CALLS WERE MADE TO THE CONSUMER ON (B)(6) 2023 WITH NO RESPONSE. THE CONSUMER RESPONDED TO A FOLLOW-UP CALL ON (B)(6) 2023. SHE STATED THAT SHE WAS 52 YEARS OLD. SHE TOOK TREATMENTS BECAUSE SHE HAD ALLERGY INDUCED ASTHMA AND HAD AN INHALER ON HAND. THE MEDICATION SHE TOOK WAS ALBUTEROL WITH A DILUTION RATIO OF 0.083%. SHE STATED DID NOT CLEAN THE UNIT SINCE SHE HAD IT FOR A DAY AND A HALF. SHE WOULD RINSE THE UNIT OUT AND LET IT AIR DRY BETWEEN USES. SHE STATED SHE DID ONE TREATMENT AT 8 AM AND THEN

  Patient problems: Dyspnea

  MAUDE report 16375967 ↗
• InjuryJan 26, 2021No Flow; No Flow

  ON (B)(6) 2021, A CARETAKER OF THE END USER OF THE NEBULIZER UNIT REPORTED THAT CONSUMER (USER) WENT TO THE HOSPITAL ON (B)(6) 2021 BECAUSE SHE WAS NOT BREATHING. THE EMERGENCY MEDICAL TECHNICIAN (EMT) STATED THE UNIT WAS NOT NEBULIZING. CONSUMER WAS ADVISED TO STOP USING THE UNIT. THE CONSUMER IS USING THE ADAPTER AND HAS OWNED THE UNIT FOR ONE YEAR. SHE IS USING THE UNIT AS MANY TIMES AS SHE NEEDS IT THROUGHOUT THE DAY AND NIGHT (SIX TO EIGHT TIMES A DAY, TWO TIMES AT NIGHT). CONSUMER DOES NOT HAVE A BACKUP NEBULIZER. CONSUMER RETURNED FROM THE HOSPITAL ON (B)(6) 2021 AND HAS BEEN USING AN INHALER. THE CAREGIVER STATED THAT SHE PUTS 2.5 ML OF MEDICATION IN THE CUP. THE CAREGIVER THINKS THAT THE VISITING NURSE CHANGED THE NEBULIZER KIT 2.5 WEEKS PRIOR. THE NEBULIZER KIT IS NOT FROM OMRON BUT IT IS HUDSON RCI. SHE DOES NOT KNOW WHEN THE FILTER WAS LAST CHANGED. IF YOU TAKE THE AIR HOSE OFF, YOU CANNOT FEEL AIR COMING FROM THE COMPRESSOR WITHOUT THE TUBING CONNECTED AND WITH THE TUBING CONNECTED BUT NOT THE MEDICINE CUP, STILL CANNOT FEEL AIR COMING OUT. NO CONDENSATION IN THE HOSE. THEY ARE NOT TILTING THE MEDICINE CUP TOWARD THEM. THE UNIT IS SITTING ON A FLAT, FIRM SURFACE. THE B

  Patient problems: Apnea

  MAUDE report 11234108 ↗
• InjuryJan 21, 2021No Flow; No Flow

  ON (B)(6) 2021, A CARETAKER OF THE END USER OF THE NEBULIZER UNIT REPORTED THAT CONSUMER (USER) WENT TO THE HOSPITAL ON (B)(6) 2021 BECAUSE SHE WAS NOT BREATHING. THE EMERGENCY MEDICAL TECHNICIAN (EMT) STATED THE UNIT WAS NOT NEBULIZING. CONSUMER WAS ADVISED TO STOP USING THE UNIT. THE CONSUMER IS USING THE ADAPTER AND HAS OWNED THE UNIT FOR ONE YEAR. SHE IS USING THE UNIT AS MANY TIMES AS SHE NEEDS IT THROUGHOUT THE DAY AND NIGHT (SIX TO EIGHT TIMES A DAY, TWO TIMES AT NIGHT). CONSUMER DOES NOT HAVE A BACKUP NEBULIZER. CONSUMER RETURNED FROM THE HOSPITAL ON (B)(6) 2021 AND HAS BEEN USING AN INHALER. THE CAREGIVER STATED THAT SHE PUTS 2.5 ML OF MEDICATION IN THE CUP. THE CAREGIVER THINKS THAT THE VISITING NURSE CHANGED THE NEBULIZER KIT 2.5 WEEKS PRIOR. THE NEBULIZER KIT IS NOT FROM OMRON BUT IT IS HUDSON RCI. SHE DOES NOT KNOW WHEN THE FILTER WAS LAST CHANGED. IF YOU TAKE THE AIR HOSE OFF, YOU CANNOT FEEL AIR COMING FROM THE COMPRESSOR WITHOUT THE TUBING CONNECTED AND WITH THE TUBING CONNECTED BUT NOT THE MEDICINE CUP, STILL CANNOT FEEL AIR COMING OUT. NO CONDENSATION IN THE HOSE. THEY ARE NOT TILTING THE MEDICINE CUP TOWARD THEM. THE UNIT IS SITTING ON A FLAT, FIRM SURFACE. THE B

  Patient problems: Apnea

  MAUDE report 11207142 ↗