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

Model Number 866389

Device Problems Insufficient Information (3190); No Visual Prompts/Feedback (4021)

Patient Problems Stomach Ulceration (4488); Insufficient Information (4580)

Event Date 09/05/2023

Event Type  Death  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that the patient was wearing the tele device and connected to piic when they died and they want to know what happened.It is unclear at this time if the device caused or contributed to the patient death.

Manufacturer Narrative

A philips remote support engineer (rse) spoke with the customer and gathered audit logs for analysis.The customer alleged the patient died wearing tel8 during the hours of 3-6am, on (b)(6) 2023 at the coronary care unit (ccu).The cause of death per physician was a peptic perforation.The rse stated that "the unit was offline according to the logs between 01:00 and 03:43, so i think the customer knows this and is wondering why it wasn¿t working during this time.They have no accurate time of death and there is no asystole in the logs so the death must have happened during this time." "looking at the data it appears the patient was discharged.I think this was user error." the remote service engineer confirmed that there was no malfunction found with the piic ix, and all data was present for telemetry 8.What caused the issue to occur was an user error discharging the patient and not having them monitored during the incident.Based on the information available and the testing conducted, the cause of the reported problem was a user error in patient discharge.The reported problem was not confirmed.

• 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: 17780764
• MDR Text Key: 323831567
• Report Number: 1218950-2023-00670
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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?: No
• 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: 09/14/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 1 KG