FDA Adverse Event Malfunction Summary report: N

KING VISION PORTABLE VIDEO LARYNGOSCOPE KIT

MDR report key: 3893482 · Received June 16, 2014

Report

Report Number
3893482
Event Type
Malfunction
Date Received
June 16, 2014
Date of Event
April 9, 2014
Report Date
June 16, 2014
Manufacturer
KING SYSTEMS CORP.
Product Code
CCW
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MN, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THERE WERE TWO DEVICE-RELATED OCCURRENCES OF THE KING VISION PORTABLE VIDEO LARYNGOSCOPE IN A THREE-DAY PERIOD. THE FIRST OCCURRENCE WAS THAT THE CREW MEMBER ATTEMPTED TO USE THE KING VISION TO INTUBATE A PATIENT AND OBSERVED THAT THE BATTERY COMPARTMENT COVER WAS OFF. THE CREW MEMBER PLACED THE COVER BACK ON AND THE SCOPE WOULD NOT TURN ON. THE SCOPE WAS SET ASIDE AND INTUBATION WAS COMPLETED WITH STANDARD LARYNGOSCOPE. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. FOLLOW UP: ONE OF THE THREE BATTERIES HAD BEEN PLACED IN THE WRONG DIRECTION. EXPERIENCED STAFF INDICATED CONTRIBUTING FACTORS TO BE POOR EQUIPMENT DESIGN, EXCESSIVE DISTRACTIONS AND HASTE. ON A DIFFERENT DAY, THE KING VISION WAS FOUND TO BE INOPERABLE DURING THE TREATMENT OF A MULTI-TRAUMA PATIENT. THERE WAS ANOTHER KING VISION AVAILABLE ON A SECOND RIG THAT WAS AT THE SCENE AND SO THAT ONE WAS USED TO INTUBATE THE PATIENT. THE NON-OPERATIONAL SCOPE WAS PULLED FROM SERVICE. INSPECTION OF THE DEVICE REVEALED THAT THE BATTERIES WERE INCORRECTLY INSERTED AND THAT IS WHY THE UNIT DID NOT WORK. EXPERIENCED STAFF LISTED CONTRIBUTING FACTORS AS BEING A POOR EQUIPMENT DESIGN, EXCESSIVE DISTRACTION AND HASTE.FURTHER FOLLOW UP: CHANGING BATTERIES IN THE DEVICE WAS PART OF THE TRAINING, BUT THE DEVICE IS NOT USED FREQUENTLY AND SO STAFF MAY BE NOT RECALL THE CORRECT STEPS.THE BLACK STRIP (RIBBON) MUST BE PLACED PROPERLY UNDER ALL THREE BATTERIES (3 AAA SIZE ALKALINE BATTERIES) TO ASSURE EASE OF REMOVAL. STAFF HAVE EXPERIENCED PROBLEMS WITH THE BLACK STRIP AND HAVE FOUND THAT IF IT IS JUST PUSHED DOWN, THE BATTERIES MAY NOT MAKE CORRECT CONTACT AND THAT THE BOTTOM BATTERY HAS TO GET DUG OUT. ALSO, IF THE BATTERIES ARE NOT IN PROPER PLACE, THE COVER IS HARD TO OPEN. IT WAS REPORTED THAT SOME STAFF ARE USING A COIN TO OPEN THE COMPARTMENT WHEN IT IS DIFFICULT TO OPEN. STAFF INVOLVED RECEIVED FOLLOW UP AND TRAINING. THIS DEVICE IS NOT NEW TO THIS FACILITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
353448 KING VISION PORTABLE VIDEO LARYNGOSCOPE KIT LARYNGOSCOPE, RIGID CCW KING SYSTEMS CORP. KVLKIT3 *
353449 KING VISION PORTABLE VIDEO LARYNGOSCOPE KIT LARYNGOSCOPE, RIGID CCW KING SYSTEMS CORP. KVLKIT3 *

Patients

Seq Age Sex Outcome Treatment
1 *