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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP60

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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP60 Back to Search Results
Model Number 862450
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  Malfunction  
Event Description

The customer called philips to report ¿the alarm disappears¿ on their mp60 bedside monitor. The device was not in use on a patient at the time of event, there was no adverse event reported.

 
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Brand NameINTELLIVUE MP60
Type of DeviceINTELLIVUE MP60
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 street
cambridge, MA 02141
MDR Report Key12225752
MDR Text Key263428809
Report Number9610816-2021-10254
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK151681
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number862450
Device Catalogue Number862450
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/14/2021
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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