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

Model Number 300-200-000

Device Problems No Display/Image (1183); Mechanical Problem (1384)

Patient Problem Cardiac Arrest (1762)

Event Date 11/01/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the reporter, the device was being used to deliver patient care for a patient in cardiac arrest.Upon attempting to intubate the patient, the display went blank and the light failed.The device was withdrawn from the oral cavity and was repowered.The display came back on along with the light.Attempts to use the device again failed for a total of 3 times.After the failures, the patient was not intubated.A bls airway was established using a king airway.Further testing revealed similar outcomes.Two other batteries were tested with the device and the issues continued.The patient eventually expired.The death was not related to the device failure.

• Brand Name: MCGRATH LARYNGOSCOPE
• 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: 12967451
• MDR Text Key: 281977850
• Report Number: 3010244187-2021-00008
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-200-000
• Device Catalogue Number: 300-200-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2021
• 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): Death; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White