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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Cardiopulmonary Arrest (1765)

Event Type  malfunction  

Manufacturer Narrative

The remote biomed checked the issue in the alarm logs.The biomed confirmed that the customer was not familiar with how to store settings changes.This supports that the reported issue was not caused by a product malfunction, but by the used not being familiar with storing settings the reported problem was traced to wrong user handling.The device remains at the customer site.This complaint was a not a malfunction it was due to customer not be able to configure settings and what the customer expected on the device.Which the biomed reconfigured the device to alarm red for leads off, and then tested the device.We will consider that the customer resolved the issue as no subsequent related calls were found.Device is back in use and working to specifications.Since there was no identified malfunction of the device, no patient characteristics are needed.None will be pursued.

Event Description

The customer called philips to report that the device was not configured to alarm "red" for leads off.This is being reported as a serious injury.The biomed reported that the patient coded and then was resuscitated.No further information is available.

• 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: nancy ataide ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6328927
• MDR Text Key: 67602133
• Report Number: 9610816-2017-00034
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/30/2015

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: 01/30/2015
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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