MAUDE Adverse Event Report: BIO-MEDICAL OXYGEN BLENDER C3#83307; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number 023H07B

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This letter is to inform the food and drug administration that (b)(4), llc will not be submitting a response to medwatch (b)(4) as (b)(4), llc is not the manufacture of the device in question.(b)(4), llc received medwatch, (b)(4), on june 22, 2021.Upon investigation, (b)(4) identified that the device in question was not manufactured by (b)(4).The following points help conclude that the device in question was not manufactured by (b)(4).Applicable supporting documentation is included.Although the medwatch did not indicate the device's model number; the serial number, (b)(6), provided did not match any serial numbers assigned by (b)(4); and the initial reporter was contacted on june 21, 2021 for additional information.The initial reporter provided (b)(4) a copy of the repair documentation completed on the unit by a third party, consolidated logistical services inc.The repair documentation, invoice number (b)(4), confirmed that the device was not manufactured by (b)(4).(b)(4)identified that the manufacturer of the device in question is bio-med devices, inc.Bio-med devices, inc.Was contacted on june 22, 2021 with all of the information provided to (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: OXYGEN BLENDER C3#83307
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): BIO-MEDICAL
• MDR Report Key: 17535108
• MDR Text Key: 321171244
• Report Number: MW5142007
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 023H07B
• Patient Sequence Number: 1