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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR Back to Search Results
Model Number 865240
Device Problem No Device Output (1435)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  malfunction  
Event Description
The customer reported that the intellivue mx800 patient monitor is frozen and they needed to cold start the device to get it operational again.It is unknown whether the device was in use monitoring a patient at the time of the reported malfunction.No death or patient / user injury or harm was reported.
 
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Brand Name
INTELLIVUE MX800 PATIENT MONITOR
Type of Device
INTELLIVUE MX800 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 Key12473282
MDR Text Key271457928
Report Number9610816-2021-10346
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838020733
UDI-Public00884838020733
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865240
Device Catalogue Number865240
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/18/2020
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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