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

Model Number	2015.C
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): laryngoscope.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 03 jan 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
It was reported that the batteries in both seem faulty.On one the light flashes quickly and then shut off.The second does not consistently turn on.Airlife received a single report referencing two different events, which were associated with seperate units involving the same patient.This is the secon of the two reports.Refer to 3000219639-2025-00001 for the first report.
Event or Problem Description
It was reported that the batteries in both seem faulty.On one the light flashes quickly and then shut off.The second does not consistently turn on.Airlife received a single report referencing two different events, which were associated with seperate units involving the same patient.This is the secon of the two reports.Refer to 3000219639-2025-00001 for the first report.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): laryngoscope.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 03 jan 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 (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.The investigation has reported the following "the complaint of "on one the light flashes quickly and then shut off.The second does not consistently turn on." regarding part 2015.C was not confirmed.A possible root cause of this issue could be that the batteries were dead or dying during use.A risk assessment was performed, and the ultimate risk was determined to be medium which does require reporting to the capa review board.There have been 6 other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends".

• Brand Name: INTUBRITE
• Common Device Name: MEDIUM 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: 21074718
• Report Number: 3000219639-2025-00002
• Device Sequence Number: 8427810
• Product Code: CCW
• UDI-Device Identifier: 00607411964411
• UDI-Public: (01)00607411964411(10)26520240306ADMS
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/29/2025

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: 2015.C
• Device Catalogue Number: 2015.C
• Device Lot Number: 265, 2024-03-06-ADMS
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/29/2025
• 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