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

Model Number 2003

Device Problem Inaccurate Delivery (2339)

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

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

This is a 2007 vintage blender which has never been returned for factory maintenance, in 14 years.Maintenance has assumedly been performed by the hospital themselves, or their third-party service provider.We conclude that the pm preceding the event was erroneous.The event happened in (b)(6) 2020.We did not become aware until june 2021, when the company maxtec forwarded the medwatch report to us directly.Maxtec was incorrectly identified on said medwatch form as the blender manufacturer.

Event Description

Air-oxygen blender was not delivering proper set output (oxygen %).It would only purportedly deliver meidcal air at approx 21%.Patient was put on other oxygen equipment, in nicu.There was no patient injury.See full narrative on user medwatch form # (b)(4).

• Brand Name: BIO-MED DEVICES
• Type of Device: AIR / OXYGEN BLENDER
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• MDR Report Key: 12278436
• MDR Text Key: 267050799
• Report Number: 1218704-2021-00003
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 00813841020379
• UDI-Public: 00813841020379
• Combination Product (y/n): N
• PMA/PMN Number: K925982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2003
• Device Catalogue Number: 2003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• 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