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

Model Number HT70

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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 could not verify the reported complaint.The device was tested and no failures were observed.The device passed all testing.The reported event could not be duplicated.The single board computer printed circuit board will be replaced as a precaution.

Event Description

It was reported that the ventilator display froze at the six picture screen.There was no patient involvement.

Manufacturer Narrative

An investigation was performed and the technician found that the reported problem could not be duplicated.No failure was detected.If information is provided in the future, a supplemental report will be issued.

• 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: 6083034
• MDR Text Key: 59600136
• Report Number: 2023050-2016-00675
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• 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: 03/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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