MAUDE Adverse Event Report: BIO-MED DEVICES BIO-MED DEVICES; TV-100 VENTILATOR

Model Number	TV-100
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
This ventilator was returned to the manufacturer for examination as a precaution.Mfr ran the ventilator continuously for over one week, and then placed the ventilator under extended observation and calibration test.No problems were found with this ventilator (no insufficiency in output, no ventilation stoppages, and all alarms functional).One possible theory is that the ventilator was being used in cpap mode.Another theory is that there was a setup issue at the hospital with the external tubing assembly / full vbs.

• Brand Name: BIO-MED DEVICES
• Common Device Name: TV-100 VENTILATOR
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• Manufacturer (Section G): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• Manufacturer Contact: ken close ; 61 soundview rd; guilford, CT 06437 ; 2034580202
• MDR Report Key: 22081474
• Report Number: 1218704-2025-00001
• Device Sequence Number: 15190376
• Product Code: CBK
• UDI-Device Identifier: 00813841020027
• UDI-Public: 00813841020027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TV-100
• Device Catalogue Number: 5500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown