Vivo 50, VIvo 65 004559Recalls & reported problems
Breas Medical AB · Click-On Battery · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07321820045594), received between Jun 16, 2022 and Jun 16, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2022Mechanical Problem; Mechanical Problem
THE HEALTHCARE PROVIDER REPORTED THE FOLLOWING NARRATIVE: A CLICK-ON BATTERY, WHICH WAS MOUNTED ON A VIVO 65 HANGING IN A STAND, FELL OFF. THE PATIENT WAS PLAYING NEARBY. IT WAS CLOSE THAT THE BATTERY COULD HAVE FALLEN ON THE PATIENT AND CAUSED INJURY. THE EDGE OF THE STAND HITS THE BATTERY LOCK/BUTTON. WHEN THE LOCK IS TURNED, THE BATTERY COMES LOOSE AND FALLS OFF. THE PRESCRIBER BELIVES THAT THERE IS A FAULT ON THE STAND CAUSING THE BATTERY TO COME LOOSE. IT HAD HAPPENED EARLIER. THERE WAS NO PATIENT HEALTH IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14711064 ↗
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- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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