MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH¿ MAC ENHANCED DIRECT LARYNGOSCOPE; LARYNGOSCOPE, NON-RIGID

Model Number 340-200-000

Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

This device in this report is product code: ccw, device class: 1 regulation number: (b)(4) (510k exempt).

Event Description

Medtronic received a report that during patient use, the device powered on, the led on the tip illuminated and the display then went blank a few seconds after powering on.It was stated that the screen showed 111mins while remaining blank.The staff was able to switch the battery on site and the device worked properly after the replacement of the battery.The customer indicated that the battery change caused a delay in the procedure/intubation.It was not specified the amount of time of the delay in the procedure.There was no reported adverse consequence to the patient.

• Brand Name: MCGRATH¿ MAC ENHANCED DIRECT LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, NON-RIGID
• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer (Section G): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6754999
• MDR Text Key: 81467892
• Report Number: 3010244187-2017-05000
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 340-200-000
• Device Catalogue Number: 340-200-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other