MAUDE Adverse Event Report: MCGRATH (VENDOR) MCGRATH MAC; LARYNGOSCOPE, RIGID

Model Number 300-000-000

Device Problems Electrical /Electronic Property Problem (1198); Unintended Collision (1429)

Patient Problems Death (1802); Hypoxia (1918)

Event Date 02/08/2016

Event Type  Death  

Manufacturer Narrative

Covidien reference number (b)(4).Covidien service received and tested the returned device and could not duplicate the reported battery error.The product is being returned to the original manufacturer for investigation.

Event Description

On (b)(6) 2016 in the emergency department, the customer was using the mcgrath mac video laryngoscope on a patient.Initially, the screen and light emitting diode (led) tip were not lighting up.The customer swapped out the battery for another, which also did not turn the unit on.Swapping out the battery took 1 minute.After this, the customer did a standard intubation on the patient.The patient subsequently died.The patient was in a car accident where the car went into water.The patient had major chest trauma and hypoxia.The reporter believes that the outcome was a result of the pre-existing condition, although replacing the battery did delay treatment for 30-45 seconds.

Manufacturer Narrative

(b)(4).The sample associated to this report was received and the customer reported issue could not be duplicated.  we are unable to determine the cause for this specific event however, manufacturing controls are in place to detect damage and to reduce the potential for occurrence during the manufacturing process.Information has been added to the database and trends will continue to be monitored.

• Brand Name: MCGRATH MAC
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): MCGRATH (VENDOR); 7 cross way; dalgety bay fife ; UK
• Manufacturer (Section G): MCGRATH (VENDOR); 7 cross way; dalgety bay fife ; UK
• Manufacturer Contact: ray maroofian ; 15 hampshire street; mansfield, MA 02048 ; 7606035334
• MDR Report Key: 5486711
• MDR Text Key: 39927309
• Report Number: 3010244187-2016-00002
• 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: company representative,consum
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• 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: 05/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death