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

Model Number	2003FFE5
Medical Device Problem Code	Medical Gas Supply Problem (2985)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user complained of supply cross-contamination with this blender leaking back to the supply (i.E., air feeding back through the blender and into the oxygen line).No patient injury.
Additional Manufacturer Narrative
This blender was built in 2015; it has never been returned to the manufacturer for any factory maintenance, in the 7 years since.We (the manufacturer) have examined the blender sn (b)(4), and root cause has been determined: both input fittings have no rubber duckbill check valve (nor conical filter) inside them.Whoever performed the last service on this unit should not have removed these essential original components, without replacement.

• 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: 15266676
• Report Number: 1218704-2022-00002
• Device Sequence Number: 17791992
• Product Code: BZR
• UDI-Device Identifier: 00813841020256
• UDI-Public: 00813841020256
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

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: 2003FFE5
• Device Catalogue Number: 2003FFE5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 08/22/2022
• 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