FDA Adverse Event Malfunction Summary report: N

AGILIA VP MC WIFI CA

MDR report key: 11735330 · Received April 27, 2021

Report

Report Number: 3004548776-2021-00049
Event Type: Malfunction
Date Received: April 27, 2021
Date of Event: March 31, 2021
Report Date: October 29, 2021
Manufacturer: FRESENIUS VIAL S.A.S.
Product Code: FRN
Product Problem: Yes
Report Source: Distributor report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 0

DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED TO THE REPORTED ISSUE WAS OBSERVED. DUE TO DEVICE FAILURE THE LOG COULD NOT BE EXTRACTED THEREFORE ITS REVIEW COULD NOT BE PERFORMED. THE DEVICE WAS RECEIVED AT INFUSYSTEM AND ITS REPAIR WAS PERFORMED BY THEIR TECHNICAL TEAM. THE DEVICE WAS CONSTANTLY ALARMING WITH THE TRIGGERING OF TECHNICAL ERROR 98-004 WHICH CONFIRMS THE REPORTED EVENT. AS PER TECHNICAL MANUAL THE CPU BOARD WAS REPLACED AND SENT TO BRÉZINS FOR FURTHER INVESTIGATION. UPON VISUAL CHECK A DAMAGE ON THE U7 MEMORY CHIP WAS OBSERVED. IN ORDER TO GET A CLOSER LOOK AT THE DAMAGE, A HIGH DEFINITION CAMERA WAS USED AND IT REVEALED THAT THE MEMORY CHIP WAS CRACKED IN SEVERAL DIRECTIONS. NEVERTHELESS, THE PART WAS CROSS-TESTED TO PERFORM FUNCTIONAL TESTS HOWEVER ONCE THE DEVICE WAS SWITCHED ON THE TECHNICAL ERROR 98 WAS IMMEDIATELY TRIGGERED. THE REPORTED EVENT WAS REPRODUCED AND WAS DUE TO A DAMAGED CPU BOARD FOLLOWING THE HIT OR DROP OF THE REPORTED DEVICE. TO OUR KNOWLEDGE THIS COMPLAINT WAS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS MISUSE. FOR THIS ISSUE AS PER OUR LOCAL PROCEDURE, WE INITIATED NO ACTION.

Description of Event or Problem · 1

ERROR 98-0004 UNEXPECTED RESET OCCURRED ON START-UP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
627103	AGILIA VP MC WIFI CA	INFUSION PUMP SYSTEM	FRN	FRESENIUS VIAL S.A.S.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other