SMART MONITOR 2PSL 1028970

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-11-16 for SMART MONITOR 2PSL 1028970 manufactured by Circadiance, Llc.

Event Text Entries

[127870584] Circadiance has chosen to report instances of nurse call jacks that are damaged but still remain mechanically intact to the point where a user would be able to make a physical connection to the nurse call jack. If the user did not verify that the connection to the nurse call system was made, the user facility personnel may rely on the nurse call alarm versus relying on the integral alarm in the monitor to decide when to act. This would be an unexpected action given that this would mean that trained medical staff would ignore a primary device alarm and only respond to alarms at a nurse call station.
Patient Sequence No: 1, Text Type: N, H10


[127870585] A user facility reported that "alarm connector broken inside alarm port" occurred on a smart monitor 2psl monitor, model 1028970, serial number (b)(4). The alarm port referred to by the customer in this complaint is a female jack that allows the monitor to be connected to a hospital nurse call system. In this case, the alarm port connections have been determined to be physically broken at the point where the jack is attached to the main circuit board. At least one of the connections is still intact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006182632-2018-00026
MDR Report Key8080958
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-11-16
Date of Report2018-08-28
Date Mfgr Received2018-08-13
Device Manufacturer Date2015-06-15
Date Added to Maude2018-11-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RICHARD LORDO
Manufacturer Street1300 RODI RD.
Manufacturer CityTURTLE CREEK PA 15145
Manufacturer CountryUS
Manufacturer Postal15145
Manufacturer Phone7243879836
Manufacturer G1CIRCADIANCE
Manufacturer Street1300 RODI RD.
Manufacturer CityTURTLE CREEK PA 15145
Manufacturer CountryUS
Manufacturer Postal Code15145
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMART MONITOR 2PSL
Generic NameINFANT APNEA MONITOR
Product CodeNPF
Date Received2018-11-16
Model Number1028970
Catalog Number1028970
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCIRCADIANCE, LLC
Manufacturer Address1300 RODI RD. TURTLE CREEK PA 15145 US 15145


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-16

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