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Vmax 773835-103Recalls & reported problems

Carefusion Corporation · INSTRUMENT ASSY V62W AUTOBOX · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846446021295), received between Dec 4, 2020 and Dec 4, 2020 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Dyspnea1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED THAT A PATIENT HAD A SEVERE REACTION WITH THE MOUTHPIECE THAT WAS USED ON THE FIRST DLCO (DIFFUSING CAPACITY FOR CARBON MONOXIDE) DURING SPIROMETRY TEST. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND WAS HOSPITALIZED FOR THREE DAYS DUE TO A SEVERE REACTION THAT CAUSED HIM TO BE SEVERELY SHORT OF BREATH.

    Patient problems: Dyspnea

    MAUDE report 10946654 ↗

Other Spirometer, Diagnostic devices

All Spirometer, Diagnostic devices →

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