SMART MONITOR 2PS 1014557

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 2018-05-04 for SMART MONITOR 2PS 1014557 manufactured by Circadiance, Llc.

Event Text Entries

[108003511] Upon reviewing the nurse call (b)(6) it is obvious that the (b)(6) was physically damaged. The only plausible explanation for the level of damage see on the (b)(6) would be for the unit to have suffered an impact, such as being dropped, with the nurse call wye cable connected to the nurse call (b)(6). This complainant had returned another batch of monitors in (b)(6) 2018 for the same issue. I spoke with the complainant on (b)(6) 2018 during investigation of the previous complaints and she could not provide any specific information regarding the damaged nurse call (b)(6). She only indicated that nursing would send the unit to the biomedical department noting that the alarm port was not working. The exact mechanism that nursing used to determine that the port was not functional was not able to be ascertained. We are unsure if the damage was noticed when the unit was dropped or at some point in time after the damage had occurred. This complainant had previously indicated that they had accumulated a number of monitors over time where the nurse call (b)(6) had been damaged and had just recently decided to start having the devices repaired and that is the reason for receiving the monitors in batches. This is not indicative of a group of simultaneous failures. Circadiance advised the customer at the time of the february complaints that they should investigate how these monitors are being handled in the hospital as this type of failure is unusual and their facility had experienced a disproportionately large incidence of this type of physical damage. This failure of the nurse call (b)(6) does not compromise the ability of the monitor to monitor and detect alarm conditions. The primary alarm system in the monitor remained functional. The professional user manual clearly indicates that the nurse call feature is provided for convenience and should not be relied upon as the primary alarm system.
Patient Sequence No: 1, Text Type: N, H10


[108003512] On (b)(6) 2018 the specialty hospital of (b)(6) ((b)(6) hospital) returned a smart monitor 2ps infant apnea monitor model number 1014557 (serial number (b)(4)) with the complaint that the remote alarm port does not work. The circadiance service technician confirmed the complaint and documented that the nurse call (b)(6) is damaged. If the unit was used with the damaged nurse call (b)(6), the monitor may not transmit an alarm to the hospital nurse call system.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006182632-2018-00022
MDR Report Key7488750
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-05-04
Date Mfgr Received2018-04-13
Device Manufacturer Date2013-01-16
Date Added to Maude2018-05-04
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 G1CIRCDADIANCE, LLC
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 2PS
Generic NameINFANT APNEA MONITOR
Product CodeNPF
Date Received2018-05-04
Returned To Mfg2018-04-25
Model Number1014557
Catalog Number1014557
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2018-05-04

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