MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER IX; CENTRAL STATION MONITOR

Model Number 866389

Device Problems Defective Alarm (1014); Loss of Data (2903)

Patient Problem Fall (1848)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

A philips clinical application support specialist (cass) logged into the customers system in order to troubleshoot the issue.The cass reviewed the audit logs and confirmed that the reported event occurred.The audit logs show that the equipment went offline at 1:25:00 and then the sector associated with the equipment was silenced at 1:26:51.There was no product malfunction; this is considered a user issue, as the alarms had been turned off, during the time of the reported issue.The cass informed the customer of their findings and offered to have a field service engineer (fse) go onsite to inspect the equipment however the customer declined any further support.

Event Description

The customer reported that a patient fell out of bed and coded on (b)(6) 2020.The customer also stated that they did not receive alarms and they were missing data from general review from 01:25 to 01:59.

Manufacturer Narrative

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 INFORMATION CENTER IX
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10854051
• MDR Text Key: 216684957
• Report Number: 1218950-2020-06943
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645
• Combination Product (y/n): N
• PMA/PMN Number: K102495
• 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: 10/27/2020

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: 866389
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening