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

Model Number	2003GE
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This blender was manufactured in 2017.It has never been returned to the manufacturer for any of the recommended factory maintenance, in the 6 years since.We conclude that improper field service played a role in this product problem.
Event or Problem Description
The user could not adjust the oxygen % with control knob as desired.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: 16953190
• Report Number: 1218704-2023-00001
• Device Sequence Number: 17010965
• Product Code: BZR
• UDI-Device Identifier: 00813841020010
• UDI-Public: 00813841020010
• 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: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 2003GE
• Device Catalogue Number: 2003GE
• 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: 04/18/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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