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

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.

• 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 Key: 17293230
• MDR Text Key: 318750290
• Report Number: 3010244187-2023-00010
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 10884521824157
• UDI-Public: 10884521824157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Date: 09/26/2014
• Device Model Number: 340-000-000
• Device Catalogue Number: 340-000-000
• 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 Received: 07/10/2023
• Supplement Dates Manufacturer Received: 06/28/2023; 08/02/2023
• Supplement Dates FDA Received: 07/30/2023; 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 Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White