FDA Adverse Event Death Summary report: N

PATIENT INFORMATION CENTER IX

MDR report key: 17885910 · Received October 6, 2023

Report

Report Number: 1218950-2023-00736
Event Type: Death
Date Received: October 6, 2023
Date of Event: September 16, 2023
Manufacturer: PHILIPS MEDICAL SYSTEMS
Product Code: MHX
UDI-DI: 00884838086715
PMA / PMN Number: K163584
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: BIOMEDICAL ENGINEER
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE CUSTOMER BIOMED SPOKE BY TELEPHONE SUPPORT WITH A PHILIPS REMOTE SUPPORT ENGINEER (RSE) WHO PERFORMED A FUNCTIONAL ANALYSIS THE DEVICE. THE RSE MADE CONFIGURATION ADJUSTMENTS TO THE PRINTER AND THE PRINTOUT WORKED NORMALLY. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE DEATH WAS NOT DUE TO PHILIPS DEVICE. HOWEVER, THE PRINTING ISSUE PROBLEM WAS CONFIRMED. THE DEVICE REMAINS AT THE CUSTOMER SITE. CORRECTED DATA: 510K HAS BEEN UPDATED TO K163584, WHICH REFLECTS THE SOFTWARE REVISION FOR PRODUCT REPORTED.

Additional Manufacturer Narrative · 0

E REPORTING INSTITUTION PHONE # (B)(6). PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 0

IT WAS REPORTED THERE WAS AN UNEXPLAINED DEATH. THE CUSTOMER REQUESTED ASSISTANCE PULLING THE DEVICE LOGS. THE CUSTOMER STATED ONLY THE PATIENT'S TREND DATA IS NEEDED. THE PHILIPS SYSTEM IS NOT SEEN AS THE CAUSE OF THE PATIENT'S CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1341722	PATIENT INFORMATION CENTER IX	PATIENT INFORMATION CENTER IX	MHX	PHILIPS MEDICAL SYSTEMS	866389		00884838086715

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Death