FDA Adverse Event Malfunction Summary report: N

INTELLIVUE INFO CENTER IX

MDR report key: 11879192 · Received May 25, 2021

Report

Report Number: 1218950-2021-10595
Event Type: Malfunction
Date Received: May 25, 2021
Date of Event: May 9, 2021
Manufacturer: PHILIPS NORTH AMERICA LLC
Product Code: MHX
UDI-DI: 00884838029620
PMA / PMN Number: K102495
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

A PHILIPS RESPONSE CENTER ENGINEER (RCE) REACHED OUT TO THE CUSTOMER FOR FURTHER INFORMATION. THE CUSTOMER WAS NOT ABLE TO PROVIDE FURTHER INFORMATION. THE RCE FOLLOWED-UP WITH THE CUSTOMER, AND WAS ADVISED TO CHECK WITH CLINICAL STAFFS IF THEY HAVE ENCOUNTERED ANY ISSUES WITH ALARMS. THE CUSTOMER INFORMED THE RCE THAT NO OTHER ISSUES HAVE BEEN REPORTED. H3 OTHER TEXT : INSUFFICIENT INFORMATION WAS PROVIDED BY THE CUSTOMER ON THE REPORTED ISSUE. THE CUSTOMER STATED THAT NO OTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

Description of Event or Problem · 0

THE CUSTOMER REPORTED THAT AN ALARM DID NOT OCCUR WHEN IT SHOULD HAVE AT THEIR PHILIPS INFORMATION CENTER IX (PIC IX).THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

Additional Manufacturer Narrative · 1

A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT AN ALARM DID NOT OCCUR WHEN IT SHOULD HAVE AT THEIR PHILIPS INFORMATION CENTER IX (PIC IX).THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
776697	INTELLIVUE INFO CENTER IX	INTELLIVUE INFO CENTER IX	MHX	PHILIPS NORTH AMERICA LLC	866023		00884838029620

Patients

Seq	Age	Sex	Outcome	Treatment
1