FDA Adverse Event Death Summary report: N

M3150 INFO CNTR LOCAL DATABASE REL N.0

MDR report key: 9665203 · Received February 4, 2020

Report

Report Number: 1218950-2020-00814
Event Type: Death
Date Received: February 4, 2020
Date of Event: December 16, 2019
Report Date: January 31, 2020
Manufacturer: PHILIPS MEDICAL SYSTEMS
Product Code: MHX
PMA / PMN Number: K081983
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED). THE CAREGIVERS WANTED TO CONFIGURE THE INOP "<SPO2 LABEL> SENSOR OFF" AS A RED OR YELLOW INOP ALARM TO PROVIDE A SEVERITY INDICATION. THE RCE INFORMED THE BIOMED THAT IT WAS NOT POSSIBLE TO CONFIGURE THE "SPO2 SENSOR OFF" AS A RED OR YELLOW INOP ALARM. THERE WAS NO PRODUCT MALFUNCTION; THE CUSTOMER WANTED TO CONFIGURE THE "SPO2 SENSOR OFF" INOP AS A RED OR YELLOW INOP ALARM. THE CUSTOMER WAS INFORMED THAT THIS WAS NOT POSSIBLE FOR THIS TYPE OF ALARM. THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE. NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

Additional Manufacturer Narrative · 1

A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THEY WANTED TO CONFIGURE THE INOP "<SPO2 LABEL> SENSOR OFF" AS RED OR YELLOW INOP TO PROVIDE A SEVERITY INDICATION. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS NOTIFIED THAT A PATIENT DIED ON (B)(6) 2019.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
128370	M3150 INFO CNTR LOCAL DATABASE REL N.0	CENTRAL STATION MONITOR	MHX	PHILIPS MEDICAL SYSTEMS	M3150

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death