MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Device Handling Problem (3265)

Patient Problem Cardiac Arrest (1762)

Event Date 07/03/2021

Event Type  Death  

Event Description

The customer reported that on (b)(6) 2021 a patient expired and they wanted to pull the audit log data.The device was in use, the patient died.

Manufacturer Narrative

A philips remote clinical support specialist (rcs) talked to the customer to troubleshoot the event.The rcs pulled the audit logs from the event and found a lot of technical alarms that were sounding but were not acknowledged.The rcs was able to determine that there was no malfunction of the philips device.The customer still had many questions regarding how technical alarms work and whether or not sound would be played for the technical alarms.The rcs talked to the customer over the phone and answered all of their questions.The customer was then provided with a list of possible causes for the technical alarms to avoid any issues in the future.Their was no malfunction of the philips device.The rcs reviewed the audit log with the customer and found that the system was alarming as expected.The rcs answered all of the customers questions to ensure that they understand how to handle and recognize technical alarms moving forward to avoid any further complications.The device remains on site and in use.

Event Description

The customer reported that on (b)(6) 2021 a patient expired and they wanted to pull the audit log data.The device was in use, the patient died.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 12199516
• MDR Text Key: 262545568
• Report Number: 1218950-2021-10729
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup

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
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/06/2021
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 36