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

Model Number	5500
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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, 2024-2026.None involved patient injury or death.We were not able to find out why all these reports were submitted at the same time.On each report, the device serial number field says "unknown", so it is not possible for us to properly parse or attribute these reports.Also, we cannot correlate the narratives to individual units (and their dhr's) that have been sent back to us for service individually in the past.We also cannot assess which and how many of these reports involve the exact same (sn) device; we believe there is such overlap.(b)(6) has not returned any large grouping of ventilators to us for service in 2026.(b)(6) has owned a sizable fleet of tv-100 ventilators for a number of years.A significant percentage of these reports involve the internal oxygen monitoring function of the tv-100 ventilator, so we believe that there is an issue at the facility involving either mis-performing the oxygen cell calibration routine or exceeding the usage life of the oxygen cell itself.We have definitely identified an issue with improper service work done by the hospital's own device-service technicians.To address this, bio-med devices will be sending our own technicians to (b)(6) to train their staff on service work on (b)(6) 2026.No malfunction trends are being seen or reported from other facilities with the tv-100 ventilator.

• 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: 25176229
• Report Number: 1218704-2026-00002
• Device Sequence Number: 16070760
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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