FDA.reportPublic FDA data

MAUDE MDR 891705

MDR report key
891705
Report number
2518422-2007-00062
Event key
0
Event type
3
Date of event
2007-07-12
Date received
2007-08-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KATHY DEPADUA
Address
1001 MURRY RIDGE LN. MURRYSVILLE PA 15866 US
Phone
724-724-7243
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1970SE SMART MONITORINFANT APNEA MONITORRESPIRONICS INC.,BZQ970SE-10970SE-10NANYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-08-090

Event Narratives#

D

Patient 1

INFORMATION WAS RECEIVED ALLEGING THE DEVICE FAILS TO ALARM. THE DEVICE WAS REPORTEDLY IN PATIENT USE, HOWEVER THERE WAS NO REPORTED PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE REPAIR EVALUATION, THE CUSTOMER'S COMPLAINT OF THE DEVICE NOT ALARMING WAS CONFIRMED. THE DEVICE WAS EVALUATED BY ENGINEERING FOR ROOT CAUSE OF THE ALARM FAILURE. THE FAILURE WAS CAUSED BY A DAMAGED ALARM BOARD. THE EXTENT OF MECHANICAL DAMAGE TO THE ALARM BOARD AND BOTTOM ENCLOSURE IS INDICATIVE OF THE DEVICE BEING DROPPED FROM A SIGNIFICANT HEIGHT OR WITH EXTENSIVE FORCE.

N

Patient 1

NA