FDA Adverse Event Malfunction Summary report: N

VIASYS

MDR report key: 1944697 · Received December 9, 2010

Report

Report Number: 2021710-2010-00062
Event Type: Malfunction
Date Received: December 9, 2010
Date of Event: November 9, 2010
Report Date: November 9, 2010
Manufacturer: CAREFUSION
Product Code: CBK
PMA / PMN Number: K013642
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. (B)(4): THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY GAS DELIVERY ENGINE. THE CAREFUSION FIELD SERVICE REP REPLACED THE GAS DELIVERY ENGINE AND RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE THAT THE DEVICE MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE USER FACILITY'S CONTROL READY TO BE PLACED BACK INTO SERVICE. THE ALLEGED FAULTY GAS DELIVERY ENGINE WAS RECEIVED BY CAREFUSION, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION FIELD SERVICE REP. IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAME REMOVED] (BIOMED) CALLED FST [FIELD SERVICE TECH] REGARDING ALARMS. GDE [GAS DELIVERY ENGINE] UPGRADED LAST WEEK AND THIS VENT HAS VISUAL ALARMS BUT NO AUDIBLE ALARM."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VIASYS	VENTILATOR, CONTINUOUS, FACILITY USE / CBK	CBK	CAREFUSION	AVEA COMP	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA