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

Model Number	2003FLEU
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Air/oxygen blender not functioning, causing delay in getting patient set up at higher oxygen level.No injury to patient.
Additional Manufacturer Narrative
(blender located in denmark) our distributor sent their own technician to the hospital to evaluate the device.He found this blender to have been "damaged by blunt force" (yet had still been kept in use).It had likely been dropped from height onto a hard floor.Furthermore, this device is ten years old, and has never been returned to the factory for recommended calibration and pm.This device was taken out of service.

• 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: 23352651
• Report Number: 1218704-2025-00004
• Device Sequence Number: 12975193
• Product Code: BZR
• UDI-Device Identifier: 00813841020355
• UDI-Public: 00813841020355
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 2003FLEU
• Device Catalogue Number: 2003FLEU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2015
• 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