FDA.reportPublic FDA data

MAUDE MDR 655239

MDR report key
655239
Report number
2518422-2005-00069
Event key
0
Event type
3
Date of event
2005-12-01
Date received
2005-12-21
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
LOU KINNEY
Address
1001 MURRY RIDGE LANE MURRYSVILLE PA 15866 US
Phone
724-724-7243
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1970 SE-10 HOSPITAL SMART MONITORINFANT APNEA MONITORRESPIRONICS, INC.BZQ970 SE-10970 SE-10NANYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-12-210

Event Narratives#

D

Patient 1

THE UNIT'S AUDIBLE ALARM WAS NOT SOUNDING TO SPECIFICATION. THE UNIT WAS REPORTEDLY IN PATIENT USE, HOWEVER THERE WAS NO REPORTED PATIENT HARM. DURING REPAIR EVALUATION, IT WAS CONFIRMED THAT THE ALARM WAS NOT FUNCTIONAL BECAUSE THE WIRING HARNESS HAD COME LOOSE. CAUSE IS UNKNOWN; HOWEVER DEVICE HAD BEEN IN USE FOR A NUMBER OF YEARS AND MAY HAVE BEEN DROPPED. THE WIRING HARNESS WAS RECONNECTED TO CORRECT THE PROBLEM.