MAUDE Adverse Event Report: BIO-MED DEVICES BIO-MED DEVICES; AIR / OXYGEN BLENDER

Model Number	2001
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This blender was manufactured and sold in 2004; it has never been returned to the manufacturer for any of the recommended factory maintenance in the 20 years since.We conclude that improper field service was at fault for leaving the device in a non-conforming state.The user facility reported the malfunction to the fda (not to the manufacturer), and the fda later re-routed the medwatch form to us.We requested from the user facility that the device be sent back to us for repair and analysis, but the user facility did not do so.
Event or Problem Description
The air / oxygen blender was apparently only supplying 21% o2, per accompanying oxygen analyzer, despite higher knob setting.No patient injury.

• Brand Name: BIO-MED DEVICES
• Common Device Name: AIR / OXYGEN BLENDER
• 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: 19584552
• Report Number: 1218704-2024-00001
• Device Sequence Number: 11645222
• Product Code: BZR
• UDI-Device Identifier: 00813841020034
• UDI-Public: 00813841020034
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K925982
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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
• Device Model Number: 2001
• Device Catalogue Number: 2001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2015
• 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