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

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.

• 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 Key: 6314316
• MDR Text Key: 66913698
• Report Number: 9610816-2017-00033
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• 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 Number: M8007A
• 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 Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1