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
- 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
- MEDLINE MDS80600Medline Industries, Inc. · STAND, INFUSION1 report
- NOV - Novum IQ 40700HUBBaxter Healthcare Corporation · STAND, INFUSION1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.