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

Model Number 865240 (MX800)

Device Problem Alarm Not Visible (1022)

Patient Problems Cyanosis (1798); Death (1802)

Event Date 12/18/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that "on (b)(6) 2019, the nursing staff found a cyanotic patient who had an asystole and was connected to the monitor.Neither an acoustic nor a visual alarm was triggered on the monitor.Resuscitation measures began immediately, the patient died.

Manufacturer Narrative

H3 and h6: a philips field service engineer (fse) went onsite to collect and review the audit log for the time of the reported event.During the onsite visit, a nurse reported that the ecg/arrhythmia alarms had been turned off by a user, though it was unknown why that was done.This was confirmed during the analysis of the audit log.The ecg/arrhythmia alarms were deactivated for bed mits3 on (b)(6) 2019 at 17:22:41 and were not switched back on until after the reported death, on (b)(6) 2019 at 05:48:00, which resulted in the fact that no ecg/arrhythmia alarms were announced during this time.This delayed the response to the patient.The customer was advised via email and letter of the investigation outcome.Additionally, onsite training for the clinical staff was requested by the customer with the regard to alarm settings/behavior.The monitor worked as intended and there was no malfunction of the device.This issue was caused by the fact that the ecg/arrhythmia alarms were switched off by the user at the reported time.The available information from this report does not support that this failure represents a systemic, design, or labeling problem.No further investigation or action is warranted.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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
• MDR Report Key: 9537626
• MDR Text Key: 173279040
• Report Number: 9610816-2020-00001
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K102562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 865240 (MX800)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 12/27/2019
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death