MAUDE Adverse Event Report: PHILIPS HEALTHCARE XPER INFORMATION MANAGEMENT SYSTEM; IMAGE INFORMATION MANAGEMENT SYSTEM

Model Number 453564243621

Device Problem Device Inoperable (1663)

Patient Problem Death (1802)

Event Date 10/23/2015

Event Type  Death  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

Event Description

On (b)(6) 2015, the customer reported that they had an issue on (b)(6) 2015, where they were unable to log-in to the philips xper workstation during customer network outage.Because they could not log in they were unable to monitor the patient with our equipment.Basic monitoring was available using alternate equipment.Customer choose to discontinue the case and the patient was transported to another facility.It was later reported the patient passed a few days later.The investigation is currently on-going.

• Brand Name: XPER INFORMATION MANAGEMENT SYSTEM
• Type of Device: IMAGE INFORMATION MANAGEMENT SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer Contact: linda morrison ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 5225960
• MDR Text Key: 31265247
• Report Number: 3003768277-2015-00096
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/23/2015

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: 453564243621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2011
• 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