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Vmax 777404-101 (UDI 10846446021394)Recalls & reported problems

Carefusion Corporation · VMAX ENCORE 22 · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846446021394), received between Feb 15, 2019 and Jun 19, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Electrical Power Problem” (1 report).

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

Device problems

  • Electrical Power Problem1
  • Output Problem1
  • Smoking1
  • Temperature Problem1

Patient problems

  • No Patient Involvement2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 19, 2023Temperature Problem; Temperature Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AMBIENT TEMPERATURE OF OBS, VMAX ENCORE 22 EXCEEDS THRESHOLD WARNING. IT WAS FOUND THAT THE TEMPERATURE OF THE MODULE (CURRENTLY) IS 37 C. THERE IS NO PATIENT INVOLVED IN THIS CASE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17153334 ↗
  • MalfunctionDec 16, 2020Output Problem; Output Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VMAX ENCORE 22 WAS EXPERIENCING HIGH LUNG VOLUMES WHILE CONNECTED TO A PATIENT. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM OR INTERVENTION TAKEN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 11016388 ↗
  • MalfunctionJan 15, 2020Smoking; Smoking

    THE CUSTOMER REPORTED DURING INSTALLATION OF A DEVICE, THE VMAX ENCORE 22 E WAS NOT FUNCTIONING. WHEN THE CUSTOMER CHANGED THE OXYGEN (O2) CELL, RECONNECTED THE VACUUM PUMP, THE BOARD STARTED TO BURN. WHEN THE CUSTOMER INSTALLED THE SAME O2 CELL ON A LOANER UNIT AFTERWARDS, THE O2 CELL WAS NOT FUNCTIONAL. THE CUSTOMER REPORTED IT IS UNCLEAR IF THE DEVICE BURNING OF THE BOARD HAD ANYTHING TO DO WITH THE O2 CELL DEVICE NOT BEING FUNCTIONAL WHEN USED. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 9593820 ↗
  • MalfunctionFeb 15, 2019Electrical Power Problem; Electrical Power Problem

    THE CUSTOMER INITIALLY REPORTED THE STATIC AND DYNAMIC COMPLIANCE VMAX DEVICE WAS UNABLE TO POWER ON. THE CUSTOMER IN CONJUNCTION WITH THE FIELD SERVICE REPRESENTATIVE DETERMINED THE MOST LIKELY CAUSED OF EVENT VMAX CART. CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT WITH THE EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 8345688 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.