AcuCare 60788Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00619498607884), received between Sep 15, 2023 and Jul 26, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO RESMED THAT THE ELBOW COMPONENT OF AN ACUCARE NON-VENTED F1-0 FULL FACE MASK DID NOT FIT AND WAS DISCONNECTED FROM THE MASK DURING INSTALLATION ON A PATIENT. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19842234 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO RESMED THAT THE ELBOW COMPONENT OF AN ACUCARE NON-VENTED F1-0 FULL FACE MASK DID NOT FIT AND WAS DISCONNECTED FROM THE MASK DURING INSTALLATION ON A PATIENT. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19842151 ↗
• InjurySep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO RESMED THAT A PATIENT, ADMITTED TO THE HOSPITAL FOR CARDIOPULMONARY ARREST FOR AN ACUTE CORONARY SYNDROME WITH STENTED TRIVESSEL INVOLVEMENT, DESATURATED DURING VENTILATION WHILE USING AN ACUCARE FULL FACE MASK. IT WAS REPORTED THAT THE VENTILATION CIRCUIT DISCONNECTED FROM THE MASK AND THE SAME ISSUE OCCURRED WHEN ANOTHER MASK FROM SAME BATCH WAS USED. IT WAS REPORTED THAT THE ¿DISCONNECTION¿ ALLEGEDLY HAPPENED DURING MASK STORAGE AND THAT THE CONNECTOR ON THE MASK (ELBOW) DID NOT FIT IN ITS HOUSING. A NEW MASK FROM A DIFFERENT BATCH WAS USED AND THE ISSUE WAS RESOLVED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17760702 ↗
• InjurySep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO RESMED THAT A PATIENT, ADMITTED TO THE HOSPITAL FOR CARDIOPULMONARY ARREST FOR AN ACUTE CORONARY SYNDROME WITH STENTED TRIVESSEL INVOLVEMENT, DESATURATED DURING VENTILATION WHILE USING AN ACUCARE FULL FACE MASK. IT WAS REPORTED THAT THE VENTILATION CIRCUIT DISCONNECTED FROM THE MASK AND THE SAME ISSUE OCCURRED WHEN ANOTHER MASK FROM SAME BATCH WAS USED. IT WAS REPORTED THAT THE ¿DISCONNECTION¿ ALLEGEDLY HAPPENED DURING MASK STORAGE AND THAT THE CONNECTOR ON THE MASK (ELBOW) DID NOT FIT IN ITS HOUSING. A NEW MASK FROM A DIFFERENT BATCH WAS USED AND THE ISSUE WAS RESOLVED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17760699 ↗