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

Model Number 865240 (MX800)

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 09/23/2019

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 between 18:45 and 19:15, the alarm indicating the absence of the spo2 signal had been sounding for more than 15 minutes for the patient in room (b)(6) when the nurse entered the room and found the patient on the edge of the bed, with the legs on the floor, the body lying on the bed, and the central venous catheter having been torn off.The patient suffered circulatory arrest and passed away.

Manufacturer Narrative

H3 and h6: the customer provided the alarm log from the central station and the trend report for the reported time frame which were forwarded to product support engineering (pse) for further evaluation.Prior to the reported time frame of 18:45 until 19:15, the alarms for room 516 were repeatedly suspended.Suspending alarms temporarily disables alarming and no alarms are announced while alarms are suspended.Alarming will resume after the configured time period of 3 minutes.During the provided time frame, several bradycardia and desat alarms were announced and suspended, as well as an asystole alarm.Based on the information provided, the monitor worked as configured.The customer was informed of the investigation results by letter.Based on the information provided, the monitor worked as intended and there was no malfunction of the device.The monitor remains in use at the customer site.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: 9161223
• MDR Text Key: 161363430
• Report Number: 9610816-2019-00261
• 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: 10/02/2019

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: 10/02/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR