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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX550 PATIENT MONITOR
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX550 PATIENT MONITOR Back to Search Results
Model Number 866066
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
It was reported that the mx550 screen on transport trolley hangs after they reset the arterial pressure during transport.They cannot acknowledge alarms on the big screen.The values on the monitor screen froze but it worked fine on the x3 so the customer could see the values.The device was not in use on a patient at the time of event, there was no patient involvement.
 
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Brand Name
INTELLIVUE MX550 PATIENT MONITOR
Type of Device
INTELLIVUE MX550 PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
Manufacturer (Section G)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM   71034
Manufacturer Contact
derek sammarco
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key13390175
MDR Text Key285015851
Report Number9610816-2022-00044
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838038783
UDI-Public00884838038783
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K131872
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
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 Number866066
Device Catalogue Number866066
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2022
Initial Date FDA Received01/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2020
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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