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

Model Number 2003FFE5

Device Problem Medical Gas Supply Problem (2985)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 305183185
• Report Number: 1218704-2022-00002
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 00813841020256
• UDI-Public: 00813841020256
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K925982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1