FDA Adverse Event Malfunction Summary report: N

VELA VENTILATOR

MDR report key: 5148911 · Received October 14, 2015

Report

Report Number: 2021710-2015-01888
Event Type: Malfunction
Date Received: October 14, 2015
Date of Event: September 14, 2015
Report Date: September 14, 2015
Manufacturer: CAREFUSION
Product Code: CBK
PMA / PMN Number: K093094
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TU
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS (FA) REPRESENTATIVE (REP) RECEIVED THE VELA FRONT PANEL ASSEMBLY AND INSTALLED IN A KNOWN GOOD UNIT FOR EVALUATION. UPON INSPECTION, THE CAREFUSION FA REP FOUND "LIQUID INGRESS" AND POWERED UP THE UNIT. THE CAREFUSION FA REP WAS ABLE TO DUPLICATE THE CUSTOMER'S ALLEGED COMPLAINT. THIS IS A KNOWN ISSUE THAT IS BEING ADDRESSED INTERNALLY WITHIN CAREFUSION.

Additional Manufacturer Narrative · 1

(B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED BY CAREFUSION.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THE TOUCH SCREEN DISPLAY WAS NONRESPONSIVE TO TOUCH AND OBSERVED LIQUID SPOTS ON THE SCREEN DISPLAY WHILE USING THE VELA VENTILATOR. THE ISSUE WAS FOUND DURING PRE-USE TESTING AND WAS IMMEDIATELY TAKEN OUT OF SERVICE. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT OR ALLEGATION OF PATIENT HARM. CAREFUSION (CFN) SHIPPED THE CUSTOMER A NEW FRONT PANEL AND THE CUSTOMER INSTALLED THE PANEL TO THE VELA VENTILATOR. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE COMPONENT FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
681277	VELA VENTILATOR	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	CAREFUSION	VELA COMP D

Patients

Seq	Age	Sex	Outcome	Treatment
1