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

Model Number 865240 (MX800)

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 04/15/2019

Event Type  Death  

Manufacturer Narrative

There was no product malfunction.The monitor was alarming as expected, and had been silenced by the customer.The fse spoke to the head nurse, who indicated that they wanted some help to understand what happened one or two hours before the death of the patient; therefore, the fse provided information from the alarm audit log, and the head nurse understood that the bedside monitor and central station were working as intended.The head nurse indicated they were not alleging the mx800 bedside monitor contributed to the death of the patient.The head nurse asked the fse to change the severity for the ecg lead off alarm; now the severity is yellow, and before it was only blue.The device remains at the customer site.There have been no subsequent calls logged for this device/issue.No further investigation or actions are warranted at this time.

Event Description

The customer reported that they wanted to investigate the events that led to the death of a patient that occurred on (b)(6) 2019.

• 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: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8529155
• MDR Text Key: 142457269
• Report Number: 9610816-2019-00108
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838020733
• UDI-Public: (01)00884838020733
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/15/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 865240 (MX800)
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• 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