MAUDE Adverse Event Report: SALTER LABS SALTER LABS BUBBLE HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Catalog Number 7900-0-25

Patient Problem Hypoxia (1918)

Event Date 04/12/2024

Event Type  Injury  

Event Description

Humidifier bottle preventing correct flow of oxygen (as set by flowmeter) to patient resulting in hypoxia.Multiple humidifier bottles with same lot number resulted in same (reproducible in same lot).Use of different lot number resolved issue.

• Brand Name: SALTER LABS BUBBLE HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SALTER LABS
• MDR Report Key: 19143043
• MDR Text Key: 340740610
• Report Number: MW5154005
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2024

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 Catalogue Number: 7900-0-25
• Device Lot Number: 458420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female