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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 Display or Visual Feedback Problem (1184)
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 the "intellivue mp70 in the room does not track/follow the leads - will show electrical activity on monitor, but shows no number for pulse rate and/or alarm for asystole. No death or patient / user injury or harm was reported.
 
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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 Key8128256
MDR Text Key129457984
Report Number9610816-2018-00338
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021300
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 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM8007A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2007
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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