MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX600 PATIENT MONITOR

Model Number 865242

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient information has been requested; not available at time of report.

Event Description

The client reported that the device has been withdrawn by the competent authority for investigations following the death of a patient.We have no other information on this; no other details are available at time of report.We have no requests for intervention from the customer.

Manufacturer Narrative

The client reported that the device has been withdrawn by the competent authority for investigations following the death of a patient.The customer biomedical engineer confirmed that no involvement of our patient monitor in terms of faults.The only fact they need is some help in considering our monitor as a ¿witness¿ of the event.We have no other information on this, no other details are available (i.E.Logfile).We have no requests for intervention from the customer.The philips field service support engineer lead stated the local competent authority confiscates the device and it remains not available for a long period of time.The customer biomedical engineer (biomed) confirmed that no involvement of the intellivue patient monitor mx600 in terms of faults.There was no product malfunction.No further investigation is warranted at this time.No parts were replaced.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 MX600 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8277156
• MDR Text Key: 134092302
• Report Number: 9610816-2019-00024
• 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: 01/21/2019

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: 865242
• Device Catalogue Number: 865242
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death