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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX450 PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS INTELLIVUE MX450 PATIENT MONITOR Back to Search Results
Model Number 866062 (MX450)
Device Problem Device Alarm System (1012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer reported that the intellivue mx450 patient monitor failed to announce an alarm.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
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Brand Name
INTELLIVUE MX450 PATIENT MONITOR
Type of Device
PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
hewlett-packard str.2
boeblingen 71034
GM   71034
MDR Report Key10617717
MDR Text Key209642562
Report Number9610816-2020-00359
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838038769
UDI-Public(01)00884838038769
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K130849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/23/2020
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
Device Operator Health Professional
Device Model Number866062 (MX450)
Device Catalogue Number866062
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received10/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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