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

Model Number 865240 (MX800)

Device Problems No Audible Alarm (1019); Disconnection (1171)

Patient Problems Death (1802); Fall (1848); Loss of consciousness (2418)

Event Date 07/12/2020

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) 2020 between 07:00 and 10:00, the patient in bed mi4137 fell and disconnected from the intellivue mx800 patient monitor, but the device did not generate any alarms.The patient was found on the floor unresponsive and passed away.

Manufacturer Narrative

The field service engineer remotely assisted the biomed with the performance assurance test of the replacement mx800 monitor.Based on the information provided, the exact cause for the reported issue could not be established and a malfunction of the device at the time of the reported event cannot be ruled out.The customer replaced the mx800 monitor, and the fse assisted the biomed via phone with the performance assurance test of the replacement monitor.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: 10326354
• MDR Text Key: 200448155
• Report Number: 9610816-2020-00255
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/12/2020

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: 865240 (MX800)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/12/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death