MAUDE Adverse Event Report: KING SYSTEMS CORPORATION (AMBU) KING VISION VIDEO LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Device Problems No Display/Image (1183); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)

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

Event Date 06/12/2019

Event Type  malfunction  

Event Description

During maam (medication-assisted airway management) intubation attempt, the king vision video laryngoscope was removed from the case and the batteries were found to be initially dead and so they were replaced.Immediately, after replacing the batteries, the device turned on but was not able to get any video feed to display on the screen.Only black with green stripe was displayed on the right side of the screen.King vision was unable to be used during maam attempt.Being able to use the king vision could have improved the outcome of the intubation.Direct laryngoscopy was used instead with a miller blade.Intubation attempt was aborted due to inability to visualize the cords.I-gel was placed successfully.Follow up: the video laryngoscope that failed was not pulled or segregated.After the supervisor checked many of the king vision devices, the supervisor discovered that he was able to recreate a similar result (no video feed display) by turning on the device before connecting the blade and then connecting the blade while the device is still activated.The supervisor did not locate any king vision devices producing anything similar to the results described above when the device was properly connected to the blade prior to turning on the device.The supervisor believes that the crew turned on the device before properly connecting to the blade.Supervisor discussed event with crew and his findings.

• Brand Name: KING VISION VIDEO LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): KING SYSTEMS CORPORATION (AMBU); 15011 herriman blvd.; noblesville IN 46060
• MDR Report Key: 8821507
• MDR Text Key: 152083084
• Report Number: 8821507
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2019,06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2019
• Event Location: Other
• Date Report to Manufacturer: 07/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1