FDA Adverse Event Malfunction Summary report: N

HT70 VENTILATOR

MDR report key: 3962638 · Received June 18, 2014

Report

Report Number: 2023050-2014-00251
Event Type: Malfunction
Date Received: June 18, 2014
Date of Event: May 15, 2014
Report Date: May 26, 2014
Manufacturer: NEWPORT MEDICAL INSTRUMENTS, INC.
Product Code: CBK
PMA / PMN Number: K090888
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COVIDIEN SERVICE ENGINEER (CSE) EVALUATED THE UNIT, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REPLACED THE MEMBRANE TO RESOLVE THIS ISSUE. (B)(4). THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO THE CIRCUIT BOARD DESIGN (CLOSE PROXIMITY OF TWO TRACES THAT WERE INSULATED WITH A MEMBRANE), THE INSULATING MEMBRANE MATERIAL, AND THE EFFECT OF ENVIRONMENTAL CONDITIONS ON THE MEMBRANE. DEGRADATION OF THE MEMBRANE CAN RESULT IN A CONDUCTIVE PATH BEING ESTABLISHED BETWEEN THE BREATH INDICATOR LED TRACE AND THE ALARMS SILENCE RESET BUTTON TRACE AT THE POINT WHERE THEY CROSS ON THE CIRCUIT BOARD. THIS CONDUCTIVE PATH RESULTS IN THE SERVED INTERMITTENT ACTIVATION/DEACTIVATION OF ALARM SILENCE RESET OR INOPERABLE ALARM SILENCE BUTTON.

Description of Event or Problem · 1

IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT AN HT70 VENTILATOR ALARM SILENCE RESET AND THE DOWN ARROW BUTTONS WERE UNRESPONSIVE. THERE WAS NO PT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
356900	HT70 VENTILATOR	CBK, NOU	CBK	NEWPORT MEDICAL INSTRUMENTS, INC.	HT70

Patients

Seq	Age	Sex	Outcome	Treatment
1