MAUDE Adverse Event Report: BIOMEDICAL DEVICES, INC. BIO-MED DEVICES OXYGEN BLENDER; BMD AIR/OXYGEN BLENDER

Model Number FOBM1000

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation because it was repaired by the bio med.Without the device being available for evaluation the reported event cannot be confirmed and a root cause cannot be determined.This type of event will continue to be monitored.It should be noted that this is being filed based on retrospective review.

Event Description

Reportedly, post repair, the biomed tested the device by putting the oxygen hose to the wall and putting the air hose into water.Then taking the air hose to the wall and the oxygen hose into water.The test failed; therefore, the check valve was bad.The blender was repaired by the biomed and not sent in for evaluation.There was no patient involvement.No additional information is available.

• Brand Name: BIO-MED DEVICES OXYGEN BLENDER
• Type of Device: BMD AIR/OXYGEN BLENDER
• Manufacturer (Section D): BIOMEDICAL DEVICES, INC.; 8 bishop ln.; madison CT 06443
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672
• MDR Report Key: 9228130
• MDR Text Key: 177834256
• Report Number: 3007409280-2019-00059
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/27/2018

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 Operator: Health Professional
• Device Model Number: FOBM1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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