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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 Problem Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Follow up report will be submitted once the investigation is complete.

 
Event Description

The customer reported that during a surgery, the monitor fell from the stand and almost hit the anesthesia tech. The customer is looking for the frame that connects on the quick release mount kit. There was no adverse event or patient/user harm reported.

 
Manufacturer Narrative

Philips cannot determine the cause for the damage to the mounting mechanism and whether this damage was the cause of the failure to remain mounted.

 
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
3000 minuteman road
andover, MA 01810
MDR Report Key5513539
MDR Text Key41038348
Report Number9610816-2016-00082
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK021300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 03/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/21/2016
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? Device Returned To Manufacturer
Date Returned to Manufacturer04/13/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/29/2002
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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