Bio-Med Devices, Inc. TV-100Recalls & reported problems
Bio-Med Devices, Inc. · Ventilator, Transport · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813841020027), received between May 23, 2025 and May 14, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Output 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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Output Problem1
- Power Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Respiratory Insufficiency1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Output Problem
VARIOUS MDR USER-FACILITY REPORTS WERE RECEIVED BY THE MANUFACTURER FROM THE FDA (IN THE WEEK BEGINNING (B)(6) 2026) WHICH HAD ALL BEEN SUBMITTED TO THE FDA BY THE SAME HOSPITAL ((B)(6) HOSPITAL IN (B)(6)). THESE REPORTS COVERED 3 YEARS OF USAGE, YEARS 2024-2026. NONE INVOLVED PATIENT INJURY OR DEATH.
Patient problems: Insufficient Information
MAUDE report 25176229 ↗MalfunctionAug 11, 2025Power Problem; Power Problem
VENTILATOR SHUT DOWN WHILE VENTILATING A PATIENT. NO HARM TO PATIENT. ALTERNATIVE VENTILATION SOURCE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22773364 ↗MalfunctionMay 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
USER DID NOT THINK THEY WERE SEEING PROPER CHEST RISE WITH PATIENT BEING VENTILATED ON THIS TRANSPORT VENTILATOR. NO INJURY OR ADVERSE EFFECT ON PATIENT; VENTILATOR WAS SWAPPED OUT AS A PRECAUTION.
Patient problems: Respiratory Insufficiency
MAUDE report 22081474 ↗
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- 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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