FDA.reportPublic FDA data

MAUDE MDR 746584

MDR report key
746584
Report number
MW1036847
Event key
0
Event type
3
Date received
2005-10-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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
1DISPOSABLE LARYNGOSCOPE*WELCH ALLYNEQN***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-10-060

Event Narratives#

D

Patient 1

THESE CAME IN AN EMERGENCY KIT (STAT KIT 600). THE LARGER ONE WAS USED IN A RESUSCITATION ATTEMPT IN OUR PARKING LOT AFTER A PT COLLAPSED ON THE WAY TO HIS CAR. THE PRODUCT FAILED. I WAS UNABLE TO INTUBATE HIM BECASUE OF A LIGHT FAILURE. THE PT DIED. THE PROBLEM SEEMS TO BE IN THE DESIGN OF THE SCREW CAP. WHILE IT WILL LIGHT, IT WILL NOT STAY LIT. WHEN USING THE DEVICE, YOU ARE HOLDING IT WITH THE LEFT HAND AND INSERTING A TUBE WITH YOUR RIGHT HAND. IT IS IMPOSSIBLE TO ADJUST THE CAP WHEN THE LIGHT GOES OUT IN THIS POSITION. I RECOMMEND YOU RECALL THIS PRODUCT IMMEDIATELY.