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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

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PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR Back to Search Results
Model Number M8007A
Device Problems Break (1069); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

 
Event Description

The customer reported that monitor fell due to movements. The monitor turns on and recognizes module m3001a, but there are some broken parts; blue connector of module m3012a is broken, the touch screen does not work; the glass is not broken, but no stripe is visible. The device was not in clinical use at the time of the incident. There was no adverse event or patient/user harm reported.

 
Manufacturer Narrative

 
Search Alerts/Recalls

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Brand NameMP70 INTELLIVUE PATIENT MONITOR
Type of DevicePATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM 71034
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
hewlett-packard str.2
boeblingen 71034
GM   71034
MDR Report Key5549741
MDR Text Key42548245
Report Number9610816-2016-00099
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK021300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 03/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM8007A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/23/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/2002
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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