MAUDE Adverse Event Report: MEDTRONIC MCGRATH MAC; LARYNGOSCOPE, RIGID

Device Problems Air Leak (1008); No Display/Image (1183); Moisture or Humidity Problem (2986); Temperature Problem (3022)

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

Event Date 02/01/2016

Event Type  malfunction  

Event Description

Laryngoscopes had moisture trapped under the screen after reprocessing in accordance with the manufacturer's instructions.As they were used, the picture was not clear or there were other defects - grainy, color not correct, or a bubble under the lens.The bubbles would sometimes come and go with the temperature of the surrounding air.Per hospital, the manufacturer has replaced the devices.

• Brand Name: MCGRATH MAC
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): MEDTRONIC; 6743 southpoint drive north; jacksonville, FL 32216
• MDR Report Key: 5808112
• MDR Text Key: 49956643
• Report Number: 5808112
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2016,07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1