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U.S. Department of Health and Human Services

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

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AIRCRAFT MEDICAL LIMITED MCGRATH; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 340-000-000
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2023
Event Type  Injury  
Manufacturer Narrative
D10 concomitant product: 300-200-000, mcgrath mac ems handle (serial#: (b)(6)) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a critical incident, the video laryngoscope had two witnessed failures during an attempted intubation.Paramedics were attempting intubation during a patient transport and the video screen seemed to fade out like the battery died (battery had 197mins on it initially, after the failure, it stated it had 167mins).Direct laryngoscope was needed to finish the intubation.Upon arrival back at the station, the paramedics were unable to replicate the failure.The patient was eventually deceased from the hospital 2 days after being admitted.After several days the handle still did not power on at all.Swapping with an alternate battery, however, the device does power on and shows 250 minutes.
 
Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was a video screen and battery failure.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a critical incident, the video laryngoscope had two witnessed failures during an attempted intubation.Paramedics were attempting intubation during a patient transport and the video screen seemed to fade out like the battery died.The battery had 197 minutes on it initially.After the failure, it stated it had 167 minutes.The same issue was experienced during an attempt by another paramedic to use the device.Direct laryngoscope was needed to finish the intubation.Upon arrival back at the station, the paramedics were unable to replicate the issue.The patient was eventually discharged from the hospital 2 days after being admitted.After several days the handle still did not power on at all.However, after swapping with an alternate battery, the device does power on and shows 250 minutes.
 
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Brand Name
MCGRATH
Type of Device
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 Key17293230
MDR Text Key318750290
Report Number3010244187-2023-00010
Device Sequence Number1
Product Code CCW
UDI-Device Identifier10884521824157
UDI-Public10884521824157
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/22/2023
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
Device Operator Health Professional
Device Expiration Date09/26/2014
Device Model Number340-000-000
Device Catalogue Number340-000-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/23/2023
Initial Date FDA Received07/10/2023
Supplement Dates Manufacturer Received06/28/2023
08/02/2023
Supplement Dates FDA Received07/30/2023
08/22/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age47 YR
Patient SexMale
Patient Weight77 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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