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

Model Number 300-000-000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, intra-operatively, when inducing anesthesia, the patient presented with difficulty in ventilation over a mask.Laryngoscopy was performed.No vocal cords were visualized and the epiglottis was very anterior and unstable.Video laryngoscopy was attempted but intubation was not possible given the impossibility of visualizing the structures.A tonsillectomy was performed as a medical intervention.

Event Description

According to the reporter, intra-operatively, when inducing anesthesia, the patient presented with difficulty in ventilation over a mask.Laryngoscopy was performed.No vocal cords were visualized and the epiglottis was very anterior and unstable.A tonsillectomy was performed as patient was diagnosis with chronic tonsillitis.Video laryngoscopy was attempted but intubation was not possible given the impossibility of visualizing the structures.There was great difficulty and it was possible to intubate the patient without using the video larongoscope and once intubated, the airway was permeable.

Manufacturer Narrative

Additional information: b5, g1 (mfr contact first and last name, email, phone), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the picture showed device sample with distorted screen.It was reported that the display was defective.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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 MAC
• 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: tanja beshear ; 5920 longbow drive; boulder, CO 80301 ; 3035306434
• MDR Report Key: 14316192
• MDR Text Key: 294264135
• Report Number: 3010244187-2022-00002
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 15060272980020
• UDI-Public: 15060272980020
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-000-000
• Device Catalogue Number: 300-000-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2022
• 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
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 65 KG