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

Model Number 340-000-000

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Battery Problem (2885)

Patient Problem Extubate (2402)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, after 1-2 minutes after powering on, the screen stopped displaying.It was a situation that the intubation was necessary because it was a patient of code blue, but the treatment was late due to the delay of the airway control, so the patient condition was worsening.Customer indicated that recannulation was performed.It was also reported that they installed the battery into another device and the condition was reproduced and verified that the defect was caused by the device's battery.

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, when the code blue occurred and tried to intubate the patient, the screen stopped displaying one to two minutes after powering on.They installed the battery to another device then the condition was reproduced, so the defect was verified that it was due to the battery and another device was brought to perform intubation.The treatment was late due to the delay of the airway control so the patient condition worsened but the code blue status of the patient was not a result of the device's failure.

Manufacturer Narrative

Evaluation summary: one product was received for evaluation and verified reported event that the battery tab and the battery was defective the device failed to meet specification as it was received.The investigation of observed condition isolated the failure to the defective.Information has been added to the database and trends will continue to be monitored.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.

• Brand Name: MCGRATH LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• MDR Report Key: 8125030
• MDR Text Key: 129057650
• Report Number: 3010244187-2018-00004
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: K882433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2019

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
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 11/08/2018; 07/31/2019
• Supplement Dates FDA Received: 03/25/2019; 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention