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

Model Number	5500
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ventilator shut down while ventilating a patient.No harm to patient.Alternative ventilation source used.
Additional Manufacturer Narrative
The ventilator was returned to the manufacturer with accessories.The separate accessory ac adapter (power supply) was found to be non-functional, with zero output voltage.So, the ventilator had been receiving zero electrical power from the wall ac source (thus the internal batteries had not been charging up).The ventilator itself was found to be functioning properly, including the alarms and power source / battery state indicators.The separate accessory ac adapter (power supply) was ten years old.The exact root cause of electrical loss inside the power supply could not be determined with certainty.

• 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: 22773364
• Report Number: 1218704-2025-00003
• Device Sequence Number: 9289215
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: 5500
• Device Catalogue Number: 5500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown