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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 Defective Alarm (1014)
Patient Problems Stroke/CVA (1770); Death (1802)
Event Date 03/24/2017
Event Type  Death  
Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

 
Event Description

The customer reported that the monitor did not announce a hr alarm. Per a nurse, the monitor showed the heart rate at 180bpm. No visual or audible alarms triggered, even though the high alarm limit was 170bpm. The incident occurred during patient monitoring around 12:02 on (b)(6) 2017 in the icu. The customer indicated that the patient had a stroke. The patient was transferred to palliative floor and passed. They do not feel that what happened in the icu had any effect on the patient outcome.

 
Manufacturer Narrative

Philips cannot rule out a malfunction of the device. The alarm logs from the central station were collected and reviewed by a philips product support engineer (pse). He stated that there was no indication for a hr/pulse alarm, based on the alarm history data. However, there was no proof that the alarm limit was set to 170. The customer has a profile of "comfort care" in which a hr limit of 200 is set; it is likely possible that this setting was used during the incident. Attempts to obtain information on the setting being used at the time of the reported incident were unsuccessful. During the evaluation of the device, the customer biomed performed simulation on the mp 70 and x2 monitor and found the equipment performing within specifications; the problem was not reproducible. With the available information, philips has not been able to establish exactly what happened at the time of the reported event, and therefore it was not possible to establish a clear cause.

 
Event Description

The customer reported that the monitor did not announce a hr alarm. Per a nurse, the monitor showed the heart rate at 180bpm. No visual or audible alarms triggered, even though the high alarm limit was 170bpm. The incident occurred during patient monitoring around 12:02 on (b)(6) 2017 in the icu. The customer indicated that the patient had a stroke. The patient was transferred to palliative floor and passed. However, they do not feel that the monitor contributed to the patient outcome.

 
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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
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6485702
MDR Text Key72548531
Report Number9610816-2017-00109
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 03/24/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received03/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/02/2006
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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