MAUDE Adverse Event Report: KING SYSTEMS KING VISION VIDEO LARYNGOSCOPE; RIGID LARYNGOSCOPE

Model Number KVLVA12

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Information (3190)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

King systems has not received a formal complaint from the complainant.All information contained within this report is based on medwatch report mw5092935 and internal investigation.The model # is assumed, as the failure mode described in medwatch report mw5092935 is consistent with that associated with recall #: z-0916-2020; res 84415.Remedial action is being completed as part of recall #: z-0916-2020; res 84415, thus no remedial action is being initiated in response to this mdr.

Event Description

As described in mw5092935: "the laryngoscope adapter was producing reversed images.".

• Brand Name: KING VISION VIDEO LARYNGOSCOPE
• Type of Device: RIGID LARYNGOSCOPE
• Manufacturer (Section D): KING SYSTEMS; 15011 herriman blvd.; noblesville, in
• Manufacturer (Section G): LIGHTHOUSE IMAGING, LLC; 765 roosevelt trail; suite 9; windham, me
• Manufacturer Contact: steven fox ; 15011 herriman blvd.; noblesville, in ; 7763150
• MDR Report Key: 9885088
• MDR Text Key: 186724186
• Report Number: 1824226-2020-00001
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/27/2020

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: No Information
• Device Model Number: KVLVA12
• Device Catalogue Number: KVLVA12
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention