MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240 (MX800)

Device Problem Image Display Error/Artifact (1304)

Patient Problem Death (1802)

Event Date 11/12/2016

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that "the wave is not showing on the bedside monitor screen".A patient death was reported.The device was used for monitoring at the time of the alleged malfunction.

Manufacturer Narrative

The device was not returned to the factory for evaluation as the philips field service engineer (fse) was already onsite.He stated that according to the customer the bedside monitor was connected with sensor plugs that were attached to the patient to monitor vital signs like blood pressure, saturated oxygen, pulse rate, heart rate, etc.However, the mx800 monitor didn¿t show any wave -- it was as if the mms was not connected to the monitor.The customer was trying to resuscitate the patient in one of the rooms in the emergency department (ed) unit, but no wave showed on the screen.They decided to transfer the patient from ed room to a different room where the patient then expired.The time the incident happened was between 11:00 a.M.And 11:30 a.M.On (b)(6) 2016.The customer needed the msl cable to be unplugged and re-plugged so that the wave could be shown.The customer has experienced this several times on several monitors in the ed unit and wants to prevent this issue from happening again and wants to know the root cause of it.The fse checked the setup if there are loose connections.He tried wiggling the msl cable but the msl cable was still intact and the wave was still showing.He was not able to reproduce the reported issue.For further assistance he called the (b)(4).(b)(4) advised the fse to check the mms extension if there were any fractures.However, the mms extension showed no sign of any.(b)(4) also advised to check the msl cable.It was noticed that if you moved the fms rack all the way to the right, the msl cable was bent with the arm.But even when it was bent, it didn't reproduce the problem.Waves were still there.(b)(4) assumed the issue could be related to (b)(4) and recommended to upgrade the monitor's software to rev k software ( k.21.42 to k.21.58).Even after several test runs by the philips field service engineer, philips was not able to fully reconstruct the incident during this time period.With the available information it was not possible to establish a clear cause.The fse upgraded all the affected monitors from k.21.42 to k.21.58.This is considered as all that is warranted for this issue.The product remains at the customer site.Although the philips field service engineer (fse) found the device to be operating normal, a malfunction of the product cannot be ruled out.No further investigation or action is warranted patient information has been requested, not available by customer.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 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: richa shah ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6151807
• MDR Text Key: 61645502
• Report Number: 9610816-2016-00317
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102562
• Number of Events Reported: 1
• 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: 11/18/2016

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: 865240 (MX800)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: 11/18/2016
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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
• Patient Outcome(s): Death