FLOW-i C30 6677300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07325710001363), received between Oct 23, 2019 and Apr 17, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Output Problem” (6 reports).

3 FDA recall records name this device's identifier, 3 still open.

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.

Recalls naming this device

1. Jun 24, 2026Open, Classified

   Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

   Z-2860-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 11, 2023Open, Classified

   Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

   Z-0988-2024 · Root cause: Software design · Recall details · FDA record ↗

3. Dec 22, 2022Open, Classified

   Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

   Z-0959-2023 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM STOPPED VENTILATING THE PATIENT. AN ALARM FOR HIGH AIRWAY PRESSURE WAS PRESENT IN THE LOG. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856739 ↗
• MalfunctionNov 26, 2024Output Problem; Output Problem

  MANUFACTURER'S REFERENCE ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784626 ↗
• MalfunctionSep 13, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS AN INCREASE IN MEASURED FICO2 DURING SURGERY. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211038 ↗
• MalfunctionJul 18, 2024Output Problem; Output Problem

  MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770356 ↗
• MalfunctionNov 2, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS IN USE SEVERAL ALARMS FOR LEAKAGE WERE GENERATED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054218 ↗
• MalfunctionMay 11, 2023Output Problem; Output Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910105 ↗
• InjuryOct 23, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  THE ANESTHESIA WORK STATION WAS CONNECTED TO A PATIENT AND THE TREATMENT WAS RUNNING IN AUTOMATIC VENTILATION WITH AUTOMATIC GAS CONTROL (AGC) SELECTED. THE ANESTHETIC AGENT WAS DELIVERED IN THE BEGINNING OF THE TREATMENT BUT AFTER CHANGE FROM SEVOFLURANE (VAPORIZER IN SLOT 1) TO DESFLURANE (VAPORIZER IN SLOT 2) THE AGENT DELIVERY STOPPED. THIS WAS DETECTED AFTER 41 MINUTES AND THE SYSTEM WAS AFTER THAT SET TO MANUAL GAS CONTROL WITH SEVOFLURANE VAPORIZER IN SLOT 1 SELECTED AND AGENT DELIVERY STARTED. THE PATIENT AWARENESS LEVEL INCREASED AND THIS WAS INDICATED BY BLOOD PRESSURE AND INCREASED RESPIRATORY RATE. NO REPORTED PSYCHOLOGICAL HARM. THE PATIENT HAS BEEN DISCHARGED. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: Awareness During Anesthesia

  MAUDE report 9226459 ↗
• InjuryOct 23, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: Awareness During Anesthesia

  MAUDE report 9223969 ↗