FDA Adverse Event Malfunction Summary report: N

CAREFUSION

MDR report key: 5101505 · Received September 24, 2015

Report

Report Number: 2021710-2015-01744
Event Type: Malfunction
Date Received: September 24, 2015
Date of Event: September 15, 2015
Report Date: September 15, 2015
Manufacturer: CAREFUSION
Product Code: CBK
PMA / PMN Number: K103211
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS (FA) REPRESENTATIVE (REP) RECEIVED THE SUSPECT DEVICE FOR EVALUATION. UPON INSPECTION OF THE AVEA UNIT EXTERNALLY, NO ANOMALIES WERE FOUND. THE CAREFUSION FA REP POWERED INTO USER MODE AND REPORTED THE UNIT IS CYCLING PROPERLY. THE CAREFUSION FA REP REPORTED NO ¿VENT INOP¿ (INOPERABLE) ALARM WAS NOT BEING DISPLAYED. THE CAREFUSION FA REP CONTINUED BY CONDUCTING EST (EXTENDED SYSTEM TEST), PASSED ALL TESTS. THE CAREFUSION FA REP CONTINUED RE-RUNNING EST TEST A COUPLE OF TIMES, AND ALL TESTS PASSED, NO ALARMS DURING OR AFTER EST TESTING. THE CAREFUSION FA REP CYCLED THE POWER INTO SERVICE MODE TO CHECK THE ERROR LOG HISTORY, THERE WERE NO ¿VENT INOP¿ RELATED EVENTS. AFTER INTERNAL INSPECTION AND RUNNING THE SUSPECT DEVICE FOR A TOTAL SEVENTY-ONE (71) HOURS, THE CAREFUSION FA REP WAS UNABLE TO DUPLICATE THE CUSTOMER¿S ALLEGED ISSUE.

Additional Manufacturer Narrative · 1

(B)(4). THE CAREFUSION FAILURE ANALYSIS TECHNICIAN WILL EVALUATE THE ALLEGED FAILED PART IF IT IS RETURNED TO THE MANUFACTURER.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP WHILE DOING THE EST MANEUVER. IT TURNED BACK ON AGAIN AND THEN DID A VENT INOP WHILE MAKING VENT CHANGES ON A TEST LUNG PRIOR TO A DEMO. NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
633208	CAREFUSION	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	CAREFUSION	AVEA

Patients

Seq	Age	Sex	Outcome	Treatment
1