MAUDE Adverse Event Report: MAXTEC, LLC MAXTEC OXYGEN BLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Device Problem Output Problem (3005)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/21/2020

Event Type  malfunction  

Event Description

Patient was brought to warmer by nicu team.Patient¿s saturations were not within parameters, oxygen was initiated and titrated upward attempting to achieve saturations within parameters unsuccessfully.Patient was on 100% oxygen without successful saturations.Patient was transferred to nicu.When placed on oxygen in nicu, baby's saturations improved almost immediately lowering oxygen to 30%.Blender in l&d (labor and delivery) room was checked by respiratory therapist lead and found to be inoperative, only providing 21% regardless of desired amount.Blender removed from room and work order completed.Device sent to consolidated logistical services for repair.Device returned to service.

• Brand Name: MAXTEC OXYGEN BLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): MAXTEC, LLC; 2305 south 1070 west; salt lake city UT 84119
• MDR Report Key: 11992769
• MDR Text Key: 255996954
• Report Number: 11992769
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/04/2021

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: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA