FDA.reportPublic FDA data

MAUDE MDR 7826643

MDR report key
7826643
Report number
3006182632-2018-00024
Event key
0
Event type
3
Date of event
2018-08-03
Date received
2018-08-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. RICHARD LORDO
Address
1300 RODI RD TURTLE CREEI PA 15145 US
Phone
724-724-7243
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SMART MONITOR 2INFANT APNEA MONITORCIRCADIANCE, LLCFLS40034003Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-290

Event Narratives#

N

Patient 1

THE SMART MONITOR 2 DEVICES INCORPORATE A START UP SEQUENCE WHERE ALL AUDIBLE AND VISUAL ALARM INDICATORS ARE ACTIVATED TO ALLOW A USER TO VERIFY THAT ALL OF THESE ELEMENTS FUNCTION CORRECTLY EVERY TIME THE MONITOR IS TURNED ON TO BE PUT INTO SERVICE. THE DEVICE THAT IS THE SUBJECT OF THIS REPORT WAS NOT IN PATIENT USE WHEN THE AUDIBLE ALARM FAILURE WAS DETECTED SUGGESTING THAT THE START UP SEQUENCE DOES PROVIDE AN APPROPRIATE MEANS FOR THE USER TO DETERMINE WHETHER OR NOT THE MONITOR'S ALARM SYSTEMS ARE FUNCTIONING PROPERLY.

D

Patient 1

A USER FACILITY CONTACTED CIRCADIANCE ON (B)(6) 2018 AND REPORTED THAT THE AUDIBLE ALARM IN THE MONITOR WAS NOT FUNCTIONING. THE MONITOR WAS NOT BEING USED WITH A PATIENT WHEN THIS ISSUE WAS IDENTIFIED.