FDA Adverse Event Malfunction Summary report: N

HT70 PLUS VENTILATOR

MDR report key: 3960676 · Received June 9, 2014

Report

Report Number: 2023050-2014-00234
Event Type: Malfunction
Date Received: June 9, 2014
Date of Event: January 1, 2014
Report Date: April 11, 2014
Manufacturer: NEWPORT MEDICAL INSTRUMENTS, INC.
Product Code: CBK
PMA / PMN Number: K111146
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PR, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

OVER THE PHONE, A COVIDIEN TECHNICAL SERVICE REP (TSE) CONFIRMED THE COMPLAINT WITH THE CUSTOMER. THE PART HAS NOT BEEN RETURNED TO COVIDIEN FOR INVESTIGATION; HOWEVER, SIMILAR COMPLAINTS OF FROZEN SCREENS ON START-UP HAVE BEEN INVESTIGATED UNDER A CORRECTIVE A PREVENTIVE ACTION. THE ROOT CAUSE WAS DETERMINED TO BE A SOFTWARE TIMING PROBLEM WITH THE TOUCH SCREEN CONTROLLER CHIP. A SOFTWARE UPDATE WAS RELEASED IN (B)(4) 2012 TO CHANGE THE VENTILATOR START-UP CODE AFFECTING THE POWER-UP OF THE TOUCH SCREEN. (B)(4)..

Additional Manufacturer Narrative · 1

(B)(4). IT WAS PREVIOUSLY REPORTED THAT THE VENTILATOR TOUCH SCREEN WOULD LOCK UP AND CONTINUE TO STAY LOCKED AFTER POWER CYCLING THE DEVICE ON AND OFF. THE DEVICE WAS RETURNED FOR INVESTIGATION. DURING THE INVESTIGATION THE COIN BATTERY WAS FOUND TO BE OUT OF SPECIFICATION. THE COIN BATTERY WAS REPLACED AND THE SOFTWARE WAS UPGRADED. THE DEVICE THEN PASSED ALL TESTING AND WAS RETURNED TO SERVICE.

Description of Event or Problem · 1

COVIDIEN RECEIVED INFO FROM A CUSTOMER IN THE USA STATING THAT THE TOUCH SCREEN ON THE HT70 PLUS VENTILATOR WAS UNRESPONSIVE. ALTHOUGH ASKED, THERE WAS NO INFO PROVIDED REGARDING PT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
333947	HT70 PLUS VENTILATOR	CBK, NOU	CBK	NEWPORT MEDICAL INSTRUMENTS, INC.	HT70

Patients

Seq	Age	Sex	Outcome	Treatment
1