MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem Alarm Not Visible (1022)

Patient Problem Death (1802)

Event Date 08/06/2020

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported a sentinel event that occurred on (b)(6) 2020, and their mp70 intellivue patient monitor failed to alarm.The patient died.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site and spoke with the customer biomed who had already retrieved the alarm review from the monitor.The fse reviewed the files, which did not indicate any alarm failure as reported by the customer.The fse confirmed an alarm was produced from the monitor for the date / time reported.The was no product malfunction.The information detailed within the device configuration files, review alarm screen and strips provided to the fse indicated the appropriate alarm was issued during the timeframe reported.The results of these findings confirmed the device was working as expected.The device remains in use 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: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10470722
• MDR Text Key: 204863585
• Report Number: 9610816-2020-00299
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K021300
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death