FDA Adverse Event Malfunction Summary report: N

NEWPORT E200 WAVE

MDR report key: 963376 · Received December 13, 2007

Report

Report Number: 2023050-2007-00045
Event Type: Malfunction
Date Received: December 13, 2007
Date of Event: October 25, 2007
Report Date: November 16, 2007
Manufacturer: NEWPORT MEDICAL INSTRUMENTS
Product Code: CBK
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER? THE VENTILATOR WAS REQUESTED TO BE RETURNED TO NEWPORT MEDICAL INSTRUMENTS, INC ON 11/16/2007. UPON RECEPTION, A FAILURE ANALYSIS REPORT AND ACTION TAKEN IN RESOLVING THIS ISSUE WILL BE SUBMITTED TO MEDWATCH PROGRAM.

Description of Event or Problem · 1

REPORTED ON NOVEMBER 16, 2007. ON EARLY OF THE THAT MONTH, BEFORE CONNECTING THE VENTILATOR TO A PT, THE DOCTOR TESTED IT AND IT WAS RUNNING WITHOUT PROBLEMS. BUT SUDDENLY, THE VENTILATOR COULD NOT DELIVER GAS AND AT THE SAME TIME IT DID NOT GIVE ANY AUDIBLE ALARMS. THE LAMPS IN THE FRONT PANEL WERE ALL LIT. THE UNIT WAS POWERED OFF AND BACK ON AGAIN BY THE USER AND IT WORKED NORMALLY. THIS UNIT OFTEN HAS THIS PROBLEM DURING TESTING. ADDITIONAL INFO RECEIVED ON DECEMBER 11, 2007: ON THE MONTH PRIOR TO ORIGINAL MONTH, ABOUT 6PM, A NEWPORT E200 VENTILATOR STOPPED DELIVERING BREATH ALTHOUGH POWER WAS CONNECTED, WHICH CAUSED CEASE OF HEARTBEAT OF THE PT WHO HAD SEVERE BRAIN DAMAGE AND WAS NOT ABLE TO BREATHE. ON THREE DAYS PRIOR TO ORIGINAL DATE, ABOUT 6PM, THE VENTILATOR WAS TESTED BEFORE USE ON A PT AND IT WAS RUNNING WITHOUT PROBLEMS. HOWEVER, IT STOPPED VENTILATION AGAIN 2 MINS LATER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEWPORT E200 WAVE	VENTILATOR	CBK	NEWPORT MEDICAL INSTRUMENTS	E200

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Death