• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR Back to Search Results
Model Number M8007A
Device Problem Device Alarm System (1012)
Patient Problem Ventricular Tachycardia (2132)
Event Type  Injury  
Manufacturer Narrative
Follow up report will be submitted after philips obtains more information concerning this event.
 
Event Description
It was reported that the patient went into ventricular tachycardia (vt), and the monitor did not alarm.The nurse did not recognize the vt, but recognized the fast rate.This was escalated to cardiology, the patient treated, and taken to the coronary care unit (ccu).There was no missed arrhythmia over night in ccu.Patient is fine but is still in ccu.
 
Manufacturer Narrative
A philips applications specialist went onsite, and spoke to the customer biomed.It was found that the arrhythmia package was "off", because the unit was not in a cardiac ward.The patient treated, and taken to the coronary care unit (ccu).There was no missed arrhythmia alarms over night in ccu.Patient is fine but is still in ccu.There was no product malfunction.The applications specialist explained the process of alarming setting and informed the biomed why the unit did not alarm.The biomed indicated that there will be an internal meeting to discuss training to make sure the users fully understand what they need know and how the monitors are used, which should help the staff become more familiar with the alarms and arrhythmia.No subsequent calls have been logged for this device/issue.No further investigation is warranted at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MP70 INTELLIVUE PATIENT MONITOR
Type of Device
PATIENT 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
denyse murphy
hewlett-packard str.2
boeblingen 71034
GM   71034
MDR Report Key6314316
MDR Text Key66913698
Report Number9610816-2017-00033
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K021300
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,Followup
Report Date 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 02/01/2017
Initial Date FDA Received02/09/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-