FDA.reportPublic FDA data

MAUDE MDR 3021092

MDR report key
3021092
Report number
3007056120-2013-00003
Event key
0
Event type
3
Date received
2013-03-20
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
CHRIS FERGUSON
Address
191 WYNGATE DRIVE MONROEVILLE PA 15146 US
Phone
412-412-4123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SMARTMONITOR 2APNEA MONITORCHILDRENS MEDICAL VENTURES , PHILIPS HEALTHCAREFLS4002Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-03-200

Event Narratives#

D

Patient 1

CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER OF A SMARTMONITOR 2 INFANT APNEA MONITOR ALARM FAILURE. THE DME STATED THAT THE DEVICE WAS NOT IN USE AT THE TIME OF THE RECORDED FAILURE AND THERE IS NO ALLEGATION OF HARM.

N

Patient 1

PR#: (B)(4). CHMV RECEIVED THE DEVICE FOR EVAL AND THE COMPLAINT ALLEGATION WAS CONFIRMED. WHEN THE DEVICE WAS INITIALLY POWERED ON THERE WAS NO AUDIBLE ALARM. ADDITIONALLY, NO AUDIBLE ALARM WAS RECORDED DURING THE SELF-TEST. HOWEVER, THE LED VISUAL INDICATORS WERE INDICATING THAT THE PROGRAMED ALARM LIMITS HAD BEEN EXCEEDED AND THAT THE AUDIBLE ALARM SHOULD HAVE BEEN SOUNDING. THE ALARM MODULE WAS REPLACED WITH A TEST MODULE AND THE DEVICE WAS FOUND TO ALARM TO SPECIFICATION. THE ORIGINAL ALARM MODULE WAS THEN RE-INSTALLED AND THE DEVICE WAS AGAIN FOUND TO ALARM TO SPECIFICATION. IT WAS DETERMINED THAT THE DEVICE HAD EXPERIENCED AN INTERMITTENT FAILURE. A FORMAL INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE OF THE RECORDED ISSUE. SMARTMONITOR 2 IS DESIGNED TO MONITOR AND RECORD PT'S BREATHING (RESPIRATION), HEART (CARDIAC) ACTIVITY. THE MONITOR ALERTS YOU IF ANY OF THESE ACTIVITIES EXCEEDS THE LIMITS PRESCRIBED BY THE PHYSICIAN. PT ALARM LIMITS ARE SET BY THE HEALTH CARE PROFESSIONAL BEFORE THE SMARTMONITOR2 IS DELIVERED TO THE PT. DURING MONITORING, WHEN THE PT'S BREATHING EFFORT AND/OR HEART ACTIVITY ARE NOT WITHIN THESE SET BOUNDARIES, AN INDICATOR LIGHT COMES ON AND AN ALARM SOUNDS. A FORMAL INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE OF THE RECORDED ISSUE AND A F/U REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED.