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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MUTLI MEASUREMENT SERVER (MMS); COMPACT PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS INTELLIVUE MUTLI MEASUREMENT SERVER (MMS); COMPACT PATIENT MONITOR Back to Search Results
Model Number M3001A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event or Problem Description
The customer reported that their device was not alarming correctly and regularly displays an x.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Additional Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
INTELLIVUE MUTLI MEASUREMENT SERVER (MMS)
Common Device Name
COMPACT PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key9978261
Report Number9610816-2020-00128
Device Sequence Number2092488
Product Code MHX
UDI-Device Identifier00884838000254
UDI-Public(01)00884838000254
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K030038
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberM3001A
Device Catalogue Number862442
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/13/2020
Supplement Date Received by Manufacturer04/13/2020
Initial Report FDA Received Date04/20/2020
Supplement Report FDA Received Date05/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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