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

Model Number 300-000-000

Device Problem No Display/Image (1183)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The serial number will be reviewed to determine the date of manufacture.The device in this report is product code: ccw, device class: 1.(b)(4) (510k exempt).Patient information (id, age, sex, weight), date of event, as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.

Event Description

The customer reported that during use on a patient the display went all black, but there was still a light on the blade with no battery indication on the display.This occurred during use on the patient while they were already in cardiac arrest.On 17-jan-2017 additional information was obtained.Per the end user, the patient with which the mcgrath malfunctioned was in cardiac arrest upon arrival when resuscitation and intubation with the mcgrath was attempted.The mcgrath video screen was black, however the light on the blade was illuminated and functioning.The medics using the device chose to use a king airway instead of using the mcgrath for direct laryngoscopy for intubation.A backup traditional laryngoscope and blade was available in their ambulance for use at the time.It was reported that later at an unspecified date and time the patient died.The death was unrelated to the device.

Manufacturer Narrative

The sample was received for analysis and the reported issue was confirmed.The devices power consumption was checked and found to be within acceptable limits both while powered and in standby.The failure is due to a battery fit issue, when the mac is pressed in a certain way it allows the battery to move in its socket breaking contact and causing the device to shut down.This problem occurs with all test batteries used which would indicate it is a tolerance problem within the mac battery compartment.The probable root cause would be wear on the edges of the mac battery compartment allowing the cell to move when pressure is applied at the positive and negative ends of the batteries.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; 7 cross way; dalgety bay fife ; UK
• Manufacturer (Section G): AIRCRAFT MEDICAL; 7 cross way; dalgety bay fife ; UK
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6261489
• MDR Text Key: 65142495
• Report Number: 3010244187-2017-00001
• 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: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

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 Model Number: 300-000-000
• Device Catalogue Number: 300-000-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: 01/11/2017
• Supplement Dates FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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