MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. AIR-OXYGEN MIXER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number 3500HL

Device Problem Output Problem (3005)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/26/2022

Event Type  malfunction  

Event Description

Infant weaned off of nasal cannula of 21% blended at 0.5 lpm to room air.It was noted that infant was desating quickly after nasal cannula removed.Infant's nares were suctioned and ns drops given with suctioning again.Still infant continued to desaturate to 78%.When nasal cannula replaced and returned to 21% at 2 lpm infant quickly increased o2 saturations to 100%.Then infant placed on a flow meter to air only from the wall on 2 lpm and infant desaturated to 78%.Nnp notified and new order for infant to be placed on hfnc with a different blender given.Initial blender taken out of service.Fda safety report id# (b)(4).

• Brand Name: AIR-OXYGEN MIXER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.
• MDR Report Key: 14885405
• MDR Text Key: 295260762
• Report Number: MW5110638
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/29/2022

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: 3500HL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 WK
• Patient Sex: Female
• Patient Weight: 2 KG