MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Unintended Application Program Shut Down (4032)

Patient Problem Cardiac Arrest (1762)

Event Date 02/07/2024

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the unit was rebooting on it's own.A patient had a heart attack and died.The hospital staff found the patient in the bathroom in cardiac arrest.Code blue procedures occurred but patient couldn't be brought back to life.The device was in use on a patient.There was a report of patient or user harm.

Manufacturer Narrative

A philips field engineer (fse) reviewed the ix logs and was not able to see any network disconnects during stated times.Powered mx40 and was able to validate connection to ix station.However, the fse replaced pc with biomed spare.Customer's biomed reviewed the clinical audit logs, revealing there were yellow alarms acknowledged during the hours of 12:00,13:00 and 14:00.Product support engineering reviewed the logs as well, indicating yellow alarms with reminders occurred continuously prior to the event, with associated acknowledgements.Based on this information, there does not appear to be any device malfunction; however, a combination of use error, alarm management, and clinical workflow during use of the device may have been factors in the patient outcome.Based on the information available and the testing conducted, the cause of the reported problem was a user error.The device was functioning as intended and there is no malfunction on the device.

Event Description

It was reported that the unit was rebooting on it's own.A patient had a heart attack and died.The hospital staff found the patient in the bathroom in cardiac arrest.Code blue procedures occurred but patient couldn't be brought back to life.The device was in use on a patient.There was a report of patient or user harm.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18885496
• MDR Text Key: 337430183
• Report Number: 1218950-2024-00181
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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