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

Model Number 2003I

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

This blender was built in 2008 and sold through our distributor / service agent in (b)(4); it has never been returned to the manufacturer for factory maintenance, in 13 years.Our agent in (b)(4) examined the blender after the event and it was concluded that some form of field service had been attempted beforehand, and the blender had been re-assembled incorrectly, and then placed back into service without a proper performance check.The top seat (which surrounds the control shaft) was found 5 full turns out of position, which is impossible if the control knob and underlying seat retention nut had not been removed.Also, as per the ifu, the user should have been using an oxygen monitor with this blender, but they apparently did not do so.

Event Description

Air-oxygen blender was put in use and was found to be only delivering air (21% oxygen).Would not deliver higher oxygen %.Patient was switched to alternate vbs (ventilator).No apparent injury to patient.

• 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: 12751473
• MDR Text Key: 282623312
• Report Number: 1218704-2021-00004
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 00813841020614
• UDI-Public: 00813841020614
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 2003I
• Device Catalogue Number: 2003I
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2007
• 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