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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 Device Alarm System (1012)
Patient Problems Bradycardia (1751); Loss of consciousness (2418)
Event Type  Malfunction  
Event Description

The customer reported that on (b)(6) 2017 at 19:00 on a bed in room four, the system did not alarm for a bradycardia event, when the patient's heart rate was at 15. This was only found when reviewing the ekg afterwards. A later alarm did sound when the patient's heart rate was 37 around 19:08. The customer indicated that the patient had a pulse of 15; the patient had lost consciousness. There was no lack of awareness to the patient's condition, and no additional treatment was necessary. No further patient data was available.

 
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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
wendy chadbourne
hewlett-packard str.2
boeblingen 71034
GM   71034
MDR Report Key6868667
MDR Text Key86591711
Report Number9610816-2017-00280
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeSW
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
Report Date 08/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/15/2017
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 Received08/25/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/13/2006
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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