MX40 1.4 GHZ SMART HOPPING 865350

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 2020-03-24 for MX40 1.4 GHZ SMART HOPPING 865350 manufactured by Philips Medical Systems.

Event Text Entries

[184641140] A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[184641141] The customer reported that the mx40/picix system did not alarm on (b)(6) 2020 at 0700 6n telemetry. The customer stated that there was a flatline patient event and they did not hear any alarms. At this time there is no additional information.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2020-01879
MDR Report Key9871054
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-24
Date of Report2020-03-06
Date of Event2020-03-03
Date Mfgr Received2020-03-06
Device Manufacturer Date2019-05-09
Date Added to Maude2020-03-24
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 ContactMS. BETTY HARRIS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786871501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMX40 1.4 GHZ SMART HOPPING
Generic NameMX40 1.4 GHZ SMART HOPPING
Product CodeDSI
Date Received2020-03-24
Model Number865350
Catalog Number865350
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-03-24

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