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U.S. Department of Health and Human Services

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

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AIRCRAFT MEDICAL LIMITED MCGRATH MAC; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 300-000-000
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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
It was reported that the device's display was black despite changing batteries.After troubleshooting, the display turned on and worked properly for a few minutes, but then went black again shortly after.The light-emitting diode (led) on the light stick continued to illuminate.There was no patient involved.
 
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Brand Name
MCGRATH MAC
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
mike bocchino
8200 coral sea st ne
mounds view, MN 55112-4391
8006464633
MDR Report Key22912805
Report Number3010244187-2025-00574
Device Sequence Number9221329
Product Code CCW
UDI-Device Identifier15060272980020
UDI-Public15060272980020
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Foreign,Health Professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/28/2025
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 Number300-000-000
Device Catalogue Number300-000-000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/14/2025
Initial Report FDA Received Date08/28/2025
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 Initial
Patient Sequence Number1
Patient SexUnknown
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