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Ventilator Trolley 007384Recalls & reported problems

Breas Medical AB · Ventilator Trolley (base unit) · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07321820073849), received between Dec 9, 2021 and Dec 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

  1. Mar 21, 2022Terminated

    Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity

    Z-0943-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Ecchymosis1

Recent adverse event reports

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

  • MalfunctionDec 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    NOTE: VOLUNTARY REPORT OF NON-SERIOUS ADVERSE EVENT. ON (B)(6) 2021, BREAS WAS NOTIFIED THAT A VIVO 50 VENTILATOR FELL OFF A TROLLEY STAND ONTO PATIENT'S FOOT, CAUSING A BRUISE WHICH DID NOT REQUIRE MEDICAL INTERVENTION. THE TROLLEY STAND FOR BREAS VENTILATOR WAS MISSING A METAL WASHER WHICH RENDERED THE MOUNTING BRACKET FOR VENTILATOR UNSTABLE.

    Patient problems: Ecchymosis

    MAUDE report 12967503 ↗

Other Stand, Infusion devices

All Stand, Infusion devices →

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