MAUDE MDR 5232425

MDR report key
5232425
Report number
9610614-2015-00014
Event key
0
Event type
3
Date of event
2015-10-23
Date received
2015-11-18
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JOHN TARTAL
Address
2225 NORTHWEST PARKWAY MARIETTA GA 30067 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ERBE APC 300ARGON PLASMA COAGULATORERBE ELEKTROMEDIZIN GMBHGEIAPC 30010132-011R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-1801. H

Event Narratives#

N

Patient 1

CURRENTLY, THE MEDICAL FACILITY IS INVESTIGATING THE SITUATION. AN OFFER WAS MADE TO HAVE ERBE INSPECT/TEST THE INVOLVED APC/ESU SYSTEM AS WELL AS DO FURTHER IN-SERVICE TRAINING, BUT WE HAVE HAD NO RESPONSE FROM THE HOSPITAL. THE FLASH FIRE IN THE AIRWAY APPEARS TO HAVE BEEN CAUSED BY IMPROPER OXYGEN MANAGEMENT AS REPORTED. THE POTENTIAL OF THIS COMPLICATION IS WELL DOCUMENTED IN PUBLISHED LITERATURE AND IS WIDELY KNOWN IN THE MEDICAL COMMUNITY. ADDITIONALLY, THERE ARE WARNINGS REGARDING THIS TYPE ISSUE IN OUR USER MANUALS. IN CONCLUSION, THERE WOULD BE NO ERBE EQUIPMENT PROBLEM THAT COULD HAVE CAUSED OR BE ATTRIBUTED TO THE SITUATION. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

D

Patient 1

IT WAS REPORTED THAT AN ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC) WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR), MODEL ICC 200 E/A, PART NUMBER 10128-205 (SERIAL NUMBER NOT PROVIDED) WAS USED IN A BRONCHOSCOPY. WHILE ACTIVATING IN THE LUNG, AN AIRWAY FIRE OCCURRED. A FLAME CAME OUT OF THE INTUBATION TUBE THAT WAS INSERTED IN THE PATIENT. THE FIRE WAS TRAVELING TOWARDS THE OXYGEN SOURCE BUT WAS STOPPED BY A STAFF MEMBER WHEN THE TUBING TO THE OXYGEN SOURCE WAS DISCONNECTED. ANOTHER MEDICAL PROFESSIONAL DISCONNECTED THE EQUIPMENT. THERE WAS A LAPSE IN COMMUNICATION BETWEEN THE DOCTOR AND NURSE ANESTHETIST CONCERNING OXYGEN MANAGEMENT WHICH CAUSED THE FIRE. TISSUE IN THE PATIENT'S AIRWAY WAS BURNT BUT THE PATIENT IS CURRENTLY DOING WELL. NEVERTHELESS, THE INCIDENT DELAYED THE PATIENT'S HEART PROCEDURE.