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

Model Number FOBM1000

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2018

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 bio med was called into the icu because the ventilator in room 17 was alarming and giving the wrong oxygen % to a patient.The ventilator in room 17 assumed the air was 20.9% oxygen and the oxygen was 100%.When the wall air was a higher percentage than that, the gas delivered to a patient had too much oxygen.It alarmed.The bio med identified that two rooms down, in room 15, the recently installed blender (sn (b)(4)) had caused this due to a valve failure.The blender in room 15 was disconnected and the ventilator in room 17 began delivering the correct oxygen percentages to the patient.The turned the alarm off.A different blender was put in room 15 and there were no longer any issues.There was no report of patient harm.The bio med reported to have performed a check valve test on the complaint device by putting the oxygen hose to the wall and putting the air hose into water and it blew some bubbles.The bio med removed the air and oxygen outlet fittings off the blender and found the spacer for the air side was in upside down.The bio med reversed it and the device worked great.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: 9228009
• MDR Text Key: 178002406
• Report Number: 3007409280-2019-00060
• 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