MAUDE Adverse Event Report: SALTER LABS INTUBRITE; PEDIATRIC SINGLE USE DISPOSABLE LARYNGOSCOPE HANDLE

Model Number	2016.C
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 25 mar 2025 has been included in the 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 is 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 a airlife product is defective or causes serious injury.
Event or Problem Description
Although no harm or injury was reported for this incident, the laryngoscope light not working during patient intubation would cause a delay in securing the patient's airway and would pose a risk of serious harm or injury to the patient.
Event or Problem Description
Although no harm or injury was reported for this incident, the laryngoscope light not working during patient intubation would cause a delay in securing the patient's airway and would pose a risk of serious harm or injury to the patient.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 25 mar 2025 has been included in the 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 is 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 causes serious injury.The complaint of "handle light would not work despite trying multiple blades" regarding part 2016.C was not confirmed.The root cause was not determined.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.This issue has already been escalated and is captured in scar-24-059 there have been 25 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.

• Brand Name: INTUBRITE
• Common Device Name: PEDIATRIC SINGLE USE DISPOSABLE LARYNGOSCOPE HANDLE
• 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: 21692071
• Report Number: 3000219639-2025-00036
• Device Sequence Number: 8773687
• Product Code: CCW
• UDI-Device Identifier: 00607411964428
• UDI-Public: (01)00607411964428
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: 2016.C
• Device Catalogue Number: 2016.C
• Device Lot Number: UNKNOWN
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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 Sex: Unknown