HT70 VENTILATOR

MDR report key: 4943802 · Received July 27, 2015

Report

Report Number: 2023050-2015-00152
Event Type: Injury
Date Received: July 27, 2015
Date of Event: June 27, 2015
Report Date: July 2, 2015
Manufacturer: NEWPORT MEDICAL INSTRUMENTS, INC
Product Code: NOU
PMA / PMN Number: K090888
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). A THIRD PARTY SERVICE PROVIDER REPLACED THE CONTROL PRINTED CIRCUIT BOARD (PCB). THE PCB WAS RETURNED FOR EVALUATION. THE SERVICE ENGINEER EVALUATED THE PCB AND VERIFIED THE REPORTED COMPLAINT. THE PCB WAS PLACED INTO A TEST VENTILATOR AND THE DEVICE ALERT MESSAGE GENERATED AFTER STARTING THE VENTILATOR WHICH COULD NOT BE CLEARED AND THE PUMP DID NOT START. THE MAIN PCBA WAS REMOVED AND INSPECTED FOR DAMAGE. THE BOOST CONVERTER CIRCUIT WAS DAMAGED DUE TO BLOWN INDUCTOR (L9).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING PATIENT USE, A VENTILATOR SUDDENLY SOUNDED AN ALARM. AN INTERNAL PRESSURE TRANSDUCER ERROR WAS CONFIRMED. THE PATIENT WAS REMOVED FROM THE VENTILATOR, MANUALLY VENTILATED AND TRANSFERRED TO ANOTHER VENTILATOR. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
487021	HT70 VENTILATOR	CONTINUOUS VENTILATOR	NOU	NEWPORT MEDICAL INSTRUMENTS, INC	HT70

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention