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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2 Back to Search Results
Model Number 865039
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
Event Type  malfunction  
Event Description
The customer reported their intellivue multi measurement server x2 indicates a loudspeaker error.It is unknown if the device was in clinical use.There was no adverse event reported.
 
Event Description
It was reported device indicates a loudspeaker error.It is unknown if the device was in clinical use.There was no adverse event reported.
 
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Brand Name
INTELLIVUE MULTI MEASUREMENT SERVER X2
Type of Device
INTELLIVUE MULTI MEASUREMENT SERVER X2
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 Key12390416
MDR Text Key268896422
Report Number9610816-2021-10322
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838000261
UDI-Public00884838000261
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K150310
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,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865039
Device Catalogue Number865039
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date08/25/2021
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2011
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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