FDA.reportPublic FDA data

MAUDE MDR 5546805

MDR report key
5546805
Report number
MW5061451
Event key
0
Event type
3
Date of event
2016-03-17
Date received
2016-04-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KING VISIONKING VISIONKING SYSTEMS (AMBU)OGH* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-0101. R

Event Narratives#

D

Patient 1

THE KING VISION VIDEO LARYNGOSCOPE WAS USED DURING A FIRST ATTEMPT OF ENDOTRACHEAL INTUBATION. DURING THE ATTEMPT, THE USER IDENTIFIED A FOREIGN OBJECT IN THE AIRWAY. THE KING VISION WAS SET DOWN WHILE THE FOREIGN OBJECT WAS BEING REMOVED. THE KING VISION WAS AGAIN PICKED UP TO BE USED FOR A SECOND ATTEMPT OF ENDOTRACHEAL INTUBATION WHEN IT WAS IDENTIFIED THAT THE UNIT WAS STILL POWERED ON, BUT THE VIDEO SCREEN WAS NO LONGER FUNCTIONING. THE KING VISION WAS SET ASIDE AND FIBEROPTIC LARYNGOSCOPY WAS USED TO PERFORM THE ENDOTRACHEAL INTUBATION.