Vivo 65 USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07321822240003), received between Aug 25, 2020 and Aug 9, 2022 — classified as 5 deaths, 1 malfunction.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K160481); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BREAS MEDICAL INC. HAS DETERMINED THAT AN EVENT OCCURRED ON (B)(6) 2022 INVOLVING A VIVO 65 VENTILATOR. THIS EVENT WAS NOT REPORTED BY THE SITE. THE DME HAS ADVISED THAT A CHILD DIED WHILE CONNECTED TO A VIVO 65 DEVICE AND IN A CAR TRAVELLING.

  Patient problems: Insufficient Information

  MAUDE report 15189632 ↗
• MalfunctionMay 20, 2022Disconnection; Display or Visual Feedback Problem

  SUMMARY OF PROBLEM REFERS TO THE ACTIVATION OF THE "DISCONNECT ALARM". IT HAS BEEN WITNESSED THAT UNDER CERTAIN CIRCUMSTANCES, THE DISCONNECT ALARM FAILS TO ACTIVATE. THIS IS OF CONCERN AS IT RELATED TO DECANNULATION OF AN INVASIVELY VENTILATED PATIENT. NOTE: THIS REPORT IS SUBMITTED RETROSPECTIVELY BECAUSE THE ORIGINAL REPORT IS NOT VISIBLE IN MAUDE DATABASE.

  Patient problems: Insufficient Information

  MAUDE report 14451061 ↗
• DeathFeb 23, 2021Defective Alarm

  UNWITNESSED DEATH OF A PATIENT OCCURRED WHILE ON THE VIVO 65. NO ALARMS WERE ACTIVATED. THERE WAS NO FORMAL COMPLAINT ISSUED BY THE HEALTH CARE FACILITY.

  Patient problems: Death

  MAUDE report 11365920 ↗
• DeathFeb 23, 2021Device Alarm System

  UNWITNESSED DEATH OF A PATIENT OCCURRED WHILE ON THE VIVO 65. NO ALARMS WERE ACTIVATED. THERE WAS NO FORMAL COMPLAINT ISSUED BY THE HEALTH CARE FACILITY.

  Patient problems: Death

  MAUDE report 11365896 ↗
• DeathFeb 23, 2021Device Alarm System

  UNWITNESSED DEATH OF A PATIENT OCCURRED WHILE ON THE VIVO 65. NO ALARMS WERE ACTIVATED. THERE WAS NO FORMAL COMPLAINT ISSUED BY THE HEALTH CARE FACILITY.

  Patient problems: Death

  MAUDE report 11365887 ↗
• DeathAug 25, 2020Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, PATIENT WAS CODED AT HOME WHILE BEING VENTILATED. 911 WAS CALLED, PATIENT WAS BAGGED ON THE WAY TO THE HOSPITAL AND THEN PLACED ON A HOSPITAL VENTILATOR.

  Patient problems: Death

  MAUDE report 10451131 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160481. One submission often covers many models, so check the product and lot details in each record.

• Z-1352-2020 · Jan 28, 2020 · Terminated
  Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protecti
• Z-2530-2018 · May 8, 2018 · Terminated
  Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanic