MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX700 PATIENT MONITOR

Model Number 865241

Device Problem Device Alarm System (1012)

Patient Problems Death (1802); No Code Available (3191)

Event Date 12/02/2019

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.(b)(6).

Event Description

The customer reported that on (b)(6) 2019 the intellivue mx700 patient monitor was not alarming.The customer stated that the patient has had a cardio-respiratory arrest (acr) and has been transferred to intensive care cardiac surgery.The nurses present report that no alarm has sounded at the unit's monitor.The patient passed away.No further information regarding the patient was available at the time of report sent.

Manufacturer Narrative

It was reported that the intellivue mx700 patient monitor was not alarming.A field service engineer (fse) went on-site to evaluate the device.Philips fse evaluated event log and the alarm history and stated that the device functioned as expected.Philips fse and pse (product specialist engineer) confirmed that the philips device functioned as expected.Philips fse updated configuration of the philips device.The device worked as intended and there was no malfunction of the device.The product remains at the customer site.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 MX700 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10122492
• MDR Text Key: 194104767
• Report Number: 9610816-2020-00187
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K110622
• 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: 05/28/2020

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: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death