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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR

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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR Back to Search Results
Model Number 866062
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Event Description
It was reported to philips that the device's battery burned.This is not applicable as there was no patient involvement.
 
Event Description
It was reported to philips that the device's battery burned.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
INTELLIVUE MX450 PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
MDR Report Key12302893
MDR Text Key265876387
Report Number9610816-2021-10287
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838038769
UDI-Public00884838038769
Combination Product (y/n)N
PMA/PMN Number
K130849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
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
Device Catalogue Number866062
Device Lot Number1320
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date07/22/2021
Initial Date Manufacturer Received 07/22/2021
Initial Date FDA Received08/10/2021
Supplement Dates Manufacturer Received07/22/2021
Supplement Dates FDA Received10/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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