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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70

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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70 Back to Search Results
Model Number 862451
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2021
Event Type  Malfunction  
Event Description

The customer reported the display on their mp70 intellivue patient monitor is black and there is no sound. It is unclear if there was an audio / alarm event associated with this malfunction. No patient involvement.

 
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Brand NameINTELLIVUE MP70
Type of DeviceINTELLIVUE MP70
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 Key11498005
MDR Text Key242726295
Report Number9610816-2021-10031
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK151681
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number862451
Device Catalogue Number862451
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date02/22/2021
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/21/2010
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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