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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR DETECTOR AND ALARM, ARRHYTHMIA

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PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number M8007A
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 12/25/2020
Event Type  Malfunction  
Event Description

Philips mp70 monitor in the room (during code and after code) alarming "asystole," but patient with pulse and zoll r series monitor correlated with accurate rate. After the code, hr on monitor was reading 70's, but rate on other device was 145. Biomed contacted to determine why the philips patient monitor was reading a different heart rate vs the other device. Biomed troubleshot and could not find any issues with the philips patient monitor or the multi-measurement server (mms) module. Staff changed the ecg pads / electrodes on the patient and that resolved the issue; it was determined that the pads on the patient caused the difference in rhythm measurements between monitors.

 
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Brand NameMP70 INTELLIVUE PATIENT MONITOR
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key11831202
MDR Text Key250831478
Report Number11831202
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/06/2021,05/05/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/17/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberM8007A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/06/2021
Device Age10 yr
Event Location Hospital
Date Report TO Manufacturer05/17/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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