MAUDE Adverse Event Report: KING SYSTEMS CORPORATION KING SYSTEM VIDEO LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2024

Event Type  Injury  

Event Description

King vision screen would not stay powered on despite battery changes.

• Brand Name: KING SYSTEM VIDEO LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): KING SYSTEMS CORPORATION
• MDR Report Key: 18858149
• MDR Text Key: 337367859
• Report Number: MW5152461
• 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: Voluntary
• Reporter Occupation: Paramedic
• Type of Report: Initial
• Report Date: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 79 KG