MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS VENTILATOR; CONTINUOUS VENTILATOR

Model Number HT70

Device Problems Poor Quality Image (1408); Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The ventilator was returned for evaluation.The service engineer evaluated the device and found the unit displayed random white lines.The display cable was not fully connected to the single board computer printed circuit board.Once the cable was reconnected, the unit displayed properly and passes all testing.

Event Description

It was reported that the ventilator display froze and was fuzzy.There was no patient involvement.

• Brand Name: HT70 PLUS VENTILATOR
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENTS, INC; 1620 sunflower ave.; costa mesa CA 92626
• Manufacturer (Section G): NEWPORT MEDICAL INSTRUMENTS, INC; 1620 sunflower ave.; costa mesa CA 92626
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 5960880
• MDR Text Key: 55380929
• Report Number: 2023050-2016-00572
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HT70
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1