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

Device Problem Power Problem (3010)

Patient Problem Airway Obstruction (1699)

Event Date 11/01/2021

Event Type  Injury  

Event Description

During a cardiac resuscitation on a patient that was apneic, an orotracheal intubation was attempted via use of the mcgrath mac video laryngoscope three times.During all three attempts, the scope powered off losing the video capabilities as well as the light on the blade thus causing the intubation attempt to secure an airway to fail.The serial number of said mcgrath mac video laryngoscope is (b)(4).The patient's airway was ultimately secured via a bls method.The blade would power off the video screen as well as the light.This power off occurred 5 times out of 13 intubation attempts during the in house testing.Fda safety report id # (b)(4).

• Brand Name: MCGRATH MAC VIDEO LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED
• MDR Report Key: 12804243
• MDR Text Key: 280822251
• Report Number: MW5105279
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White