INTELLIVUE MULTI MEASUREMENT SERVER X2 M3002A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-18 for INTELLIVUE MULTI MEASUREMENT SERVER X2 M3002A manufactured by Philips Medical Systems.

Event Text Entries

[187546999] A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[187547000] The customer reported that they have an intellivue multi measurement server x2 where the speaker is broken and requested the part number and price for a replacement speaker assembly. No information was provided whether sound was still coming from the x2. No death or patient injury or harm was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610816-2020-00094
MDR Report Key9847635
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-18
Date of Report2020-02-24
Date Mfgr Received2020-02-24
Device Manufacturer Date2011-02-16
Date Added to Maude2020-03-18
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 StreetHEWLETT-PACKARD STR.2
Manufacturer CityBOEBLINGEN 71034
Manufacturer CountryGM
Manufacturer Postal71034
Manufacturer G1PHILIPS MEDICAL SYSTEMS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTELLIVUE MULTI MEASUREMENT SERVER X2
Generic NamePATIENT MONITOR
Product CodeMHX
Date Received2020-03-18
Model NumberM3002A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer AddressHEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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