MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH; LARYNGOSCOPE, RIGID

Model Number	340-000-000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.D10 concomitant product: 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#10551402); 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#h21111004); 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#h23010704b); 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#h23020404).H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Analysis of the device noted that the battery was installed in a test mcgrath mac.The battery would not power on the unit unless firm pressure was applied to the battery, indicating a contact issue at the terminals.The positive terminal was adjusted to make contact with the mac device.After this the device was powered on, battery indicator showed 246 minutes of battery remaining.The device was left on for 10 minutes, the device functioned properly during this time.It was reported that prior to use, the following video laryngoscope batteries were used and no display on the device screen, and no led lights lit.The reported issue was confirmed.The most likely cause was traced to component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, prior to use, the following video laryngoscope batteries were used and no display on the device screen, a nd no led lights lit.There was no patient involvement.

• Brand Name: MCGRATH
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; UK KY11 9JE
• Manufacturer (Section G): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; UK KY11 9JE
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21470699
• Report Number: 3010244187-2025-00446
• Device Sequence Number: 11635761
• Product Code: CCW
• UDI-Device Identifier: 15060272980068
• UDI-Public: 15060272980068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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: 340-000-000
• Device Catalogue Number: 340-000-000
• Device Lot Number: H21030704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown