FDA Adverse Event Malfunction Summary report: N

VIASYS

MDR report key: 1525542 · Received October 26, 2009

Report

Report Number: 2021710-2009-00045
Event Type: Malfunction
Date Received: October 26, 2009
Date of Event: August 14, 2009
Report Date: October 23, 2009
Manufacturer: CAREFUSION 207, INC
Product Code: CBK
PMA / PMN Number: K013642
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADD'L 510K#: K022674, K062093, K073069. (B)(4): THE CAREFUSION POST MARKET QUALITY ASSURANCE DEPT SENT A LETTER TO THE USER FACILITY SEEKING ADD'L INFO CONCERNING THE REPORTED EVENT, THE CONDITION OF THE PT AND THE REPAIR OF THE DEVICE. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. ONCE THE USER FACILITY PROVIDES US WITH ADD'L INFO, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

(B)(4). "EVENT DESC: PT WAS ON VIASYS AVEA VENTILATOR FOR USE OF HELIOX. LOW O2 ALARM FOR SENSOR ALARMED DESPITE ATTEMPT TO RECALIBRATE WITH 100% FIO2. HELIOX WAS TURNED OFF AND PRESSURE HOSE FOR MEDICAL AIR CONNECTOR WAS ATTACHED TO BACK OF VENT. PRESSURE HOSE WAS PLACED IN THE WALL CONNECTOR. AT THAT TIME THE ALARM FOR NO ID WAS DISPLAYED ON THE SCREEN. PT'S SPO2 REMAINED AT 99%-100%. AVEA VENTILATOR WAS REMOVED FROM ROOM AND THE PT WAS PLACED ON ANOTHER VENTILATOR WITH NO DIFFICULTY." "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VIASYS	73CBK VENTILATOR, CONTINUOUS (RESPIRATOR)	CBK	CAREFUSION 207, INC	AVEA

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Other