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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3 Back to Search Results
Model Number 867030
Device Problems No Audible Alarm (1019); Unable to Obtain Readings (1516)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Phone number: (b)(6).
 
Event Description
The customer alleged that although the monitor was in use, all of the vital signs disappeared on 3 occasions, and alarms did not go off.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Event Description
The customer alleged that although the monitor was in use, all of the vital signs disappeared on 3 occasions, and alarms did not go off.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 X3
Type of Device
INTELLIVUE X3
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
MDR Report Key11423409
MDR Text Key238603127
Report Number9610816-2021-10014
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838082588
UDI-Public00884838082588
Combination Product (y/n)N
PMA/PMN Number
K171801
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 Number867030
Device Catalogue Number867030
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date03/01/2021
Initial Date Manufacturer Received 03/01/2021
Initial Date FDA Received03/05/2021
Supplement Dates Manufacturer Received03/01/2021
Supplement Dates FDA Received06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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