FDA.reportPublic FDA data

MAUDE MDR 1174263

MDR report key
1174263
Report number
1040777-2008-00001
Event key
0
Event type
3
Date of event
2008-08-01
Date received
2008-09-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ROBERT SHERBURN
Address
175 CHASTAIN MEADOWS COURT KENNESAW GA 30144 US
Phone
770-770-7704
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COUGHASSISTSECRETION CLEARANCE DEVICERESPIRONICS GEORGIA, INC.NHJCA-3000CA-3000NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-09-2201. D

Event Narratives#

D

Patient 1

INFO WAS RECEIVED FROM A CONSUMER ALLEGING HER HUSBAND MAY HAVE CONTRACTED E. COLI BACTERIA IN HIS LUNG FROM THE USE AND SETUP OF A COUGHASSIST DEVICE WHILE BEING TREATED FOR ALS AT THE MEDICAL CENTER. SHE STATED SHE FEELS THE SETTING WAS SET TOO HIGH FOR HER HUSBAND'S CONDITION AND SHE NEVER SAW A FILTER ON THE COUGH ASSIST UNIT. HER HUSBAND'S CONDITION WEAKENED AND HE LATER EXPIRED. ADDITIONAL INFO WAS REQUESTED FROM THE MEDICAL CENTER BUT NONE WAS PROVIDED.

N

Patient 1

THE SERIAL NUMBER OF THE DEVICE WAS NOT REPORTED AND THE DEVICE IS NOT BEING RETURNED TO THE MFR FOR EVALUATION. AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFO FROM THE MEDICAL CENTER BUT NONE WAS PROVIDED. DURING THIS ATTEMPT, WE ALSO MADE THE CONTACT PERSON AT THE MEDICAL CENTER AWARE OF THE CAUTION LABELING REQUIRING A NEW BACTERIAL/VIRAL FILTER TO BE ATTACHED TO THE PATIENT CIRCUIT WHEN USING THE DEVICE ON A NEW PATIENT. IN ADDITION, A FOLLOW-UP LETTER WAS MAILED.