MAUDE Adverse Event Report: SALTER LABS SALTER LABS; HUMIDIFIER, BUBBLE, W/ 6 PSI SAFETY VALVE

Model Number	7900-0-25
Medical Device Problem Codes	Partial Blockage (1065); Obstruction of Flow (2423)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
All information reasonably known as of 05 jun 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem 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.(narrative from medwatch report received-mw5154005).
Additional Manufacturer Narrative
All information reasonably known as of 05 jun 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.The information received regarding this issue was originally reported to fda.Airlife's investigation on the inicident is still ongoing as of 10 july 2024.Medwatch report received mw5154005.
Additional Manufacturer Narrative
All information reasonably known as of (b)(6) 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.The information received regarding this issue was originally reported to fda.Airlife's investigation on the incident is still ongoing as of (b)(6) 2024.Medwatch report received mw5154005 is attached.Testing of the returned product was performed for leakage, pressure, and flow.No defect were identified during the testing.In the absence of a confirmed defect a root cause cannot be determined.The ultimate risk was identified as low which does not meet the threshold for escalation to carb.
Event or Problem 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.(narrative from medwatch report received-mw5154005).

• Brand Name: SALTER LABS
• Common Device Name: HUMIDIFIER, BUBBLE, W/ 6 PSI SAFETY VALVE
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19470495
• Report Number: 3000219639-2024-00049
• Device Sequence Number: 7441839
• Product Code: BTT
• UDI-Device Identifier: 00607411700057
• UDI-Public: 00607411700057
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7900-0-25
• Device Catalogue Number: 7900-0-25
• Device Lot Number: 458420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 05/06/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/10/2024; 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female