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

Model Number	2003FFH
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The output of the blender was 21% oxygen and could not be adjusted.No patient injury.
Additional Manufacturer Narrative
This blender was manufactured and sold early in 2014; it has never been returned to the manufacturer for any of the recommended factory maintenance, in the 10 years since.We conclude that improper field service was at fault for leaving the device in a non-conforming state.After field-service re-assembly, someone did not tighten the seat nut and the control knob's collet nut properly, and mis-installed the underlying seat pn psea010.

• 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: 18519474
• Report Number: 1218704-2023-00004
• Device Sequence Number: 15089374
• Product Code: BZR
• UDI-Device Identifier: 00813841020294
• UDI-Public: 00813841020294
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 01/16/2024

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: 2003FFH
• Device Catalogue Number: 2003FFH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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