PATIENT SAFETYNET CONSOLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for PATIENT SAFETYNET CONSOLE manufactured by Masimo Corporation.

Event Text Entries

[173502487] Our biomed team received a call that the patient assignments had changed on all of our masimo central appliances. Upon inspection, the format for the primary and secondary naming convention had changed. With this change, our notification to the nurses (secondary notification system) were not firing. Manufacturer response for computer, central station, (brand not provided) (per site reporter). Mfg could determine a route cause on how the change in format occurred. They were able to get the naming format corrected but, this still provided a learning curve for our clinicians who had to learn a new process.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9544339
MDR Report Key9544339
Date Received2020-01-03
Date of Report2019-09-30
Date of Event2018-11-07
Report Date2019-09-30
Date Reported to FDA2019-09-30
Date Reported to Mfgr2020-01-03
Date Added to Maude2020-01-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePATIENT SAFETYNET CONSOLE
Generic NameSYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
Product CodeMSX
Date Received2020-01-03
Model NumberSAFETYNET
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age2 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMASIMO CORPORATION
Manufacturer Address52 DISCOVERY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-03

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