INTELLIVUE MULTI MEASUREMENT SERVER X2

Report

Report Number: 9610816-2010-00704
Event Type: Death
Date Received: November 8, 2010
Date of Event: October 29, 2010
Report Date: October 31, 2010
Manufacturer: PHILIPS MEDICAL SYSTEMS
Product Code: MHX
PMA / PMN Number: K071426
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE CUSTOMER REPORTED THAT A PT DEATH OCCURRED, BUT DID NOT HAVE DETAILED INFO TO PROVIDE. BASED ON THE AVAILABLE INFO PROVIDED, DURING A TRANSFER FROM A TELEBOX TO X2 BEDS, THERE WAS A LOT OF TIME THAT SHOWED NO DATA; CUSTOMER STATED, SHE DOES NOT KNOW WHAT HAPPENED OR WHO THE CHILD WAS. HOWEVER, WHAT THE CUSTOMER DID KNOW WAS THAT A CHILD DID EXPIRE. CUSTOMER STATED, IT WAS JUST THIS ONE PT THAT THEY WERE UNABLE TO SEE AT THE TOWER ONCE THEY TOOK THE CHILD OFF THE TELEBOX TO AN X2 BEDSIDE MONITOR. THE CUSTOMER ALSO STATED YESTERDAY THAT IT WAS OCCURRING WITH ALL THE PTS. CUSTOMER STATED SHE WAS TOLD THAT BIOMED WAS THERE YESTERDAY TO PERFORM AN UPGRADE AND WAS UNSURE IF THE UPGRADE HAD SOMETHING TO DO WITH THE INCIDENT. THE CUSTOMER WAS UNWILLING TO PROVIDE ADD'L INFO BECAUSE SHE WAS NOT THERE AT THE TIME OF THE INCIDENT. THERE IS NO INDICATION OR ALLEGATION THAT THERE WAS ANY PROBLEM WITH REAL-TIME MONITORING FOR ANY PT. THE POSSIBLE LOSS OF RETROSPECTIVE DATA POSES MINIMAL HEALTH RISK. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT A PT DEATH OCCURRED, BUT DID NOT HAVE DETAILED INFO TO PROVIDE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTELLIVUE MULTI MEASUREMENT SERVER X2		MHX	PHILIPS MEDICAL SYSTEMS	M3002A

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death