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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The logs have been evaluated and this issue has been discussed with philips product specialist, the device is designed to give yellow alarms for nibp high or nibp low but is not designed to give red alarms.Therefore, our device did not malfunction.The customer's issue has been resolved, the issue was caused by a misunderstanding of the alarm behavior.This is all that was necessary to fully resolve the issue.The device remains at the customer site.Following our investigation, we have concluded that the device did not malfunction and that the issue arose because the user had misunderstanding of the expected alarm behavior.The caregiver expected to have a yellow alarm alert as a red alarm for an issue with the nibp parameter, which the device is not designed to do.The device remains at the customer site.The device did not contribute to the patient death.The available information supports that there is no design, manufacturing, materials, or labeling problem.No further investigation or action is warranted.Since there was no identified malfunction of the device, no patient characteristics are needed.None will be pursued.

Event Description

The customer stated that the device had not alarmed and that the patient died.The nurse stated that she expected a yellow alarm to alarm as red for a nibp parameter.This is being reported as a death.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: 6328946
• MDR Text Key: 67370145
• Report Number: 9610816-2017-00036
• 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: Other
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2009
• 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