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

Model Number 340-000-000

Device Problems No Display/Image (1183); Failure to Run on Battery (1466)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

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 resuscitation, the physician intubated the blood circulation after the patient was deeply unconscious before transferring the patient to an ambulance and hospital for further treatment.During intubation, the device screen went blank due to sudden depletion of battery.The patient was ventilated with bellow until a new battery was replaced.Intervention was prolonged with manual ventilation of the patient.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the battery was defective.It was reported that the display received power but did not display an image.The reported issue was confirmed.The most likely cause was traced to a component failure.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.

Event Description

According to the reporter, after resuscitation, the physician intubated the blood circulation after the patient was deeply unconscious before transferring the patient to an ambulance and hospital for further treatment.During intubation, the device screen went blank due to sudden depletion of battery.The patient was manually ventilated with bellow until a new battery was replaced.

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.

• 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12543555
• MDR Text Key: 273677030
• Report Number: 3010244187-2021-00004
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 15060272980068
• UDI-Public: 15060272980068
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K882433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2021

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: 09/09/2021
• Device Model Number: 340-000-000
• Device Catalogue Number: 340-000-000
• Device Lot Number: H20080804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 09/28/2021; 12/17/2021
• Supplement Dates FDA Received: 10/15/2021; 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 70 KG