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

Model Number HT70 PLUS

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the ht70 plus ventilator gets stuck on the six picture screen and does not go to the normal ventilation screen.Patient involvement is unknown.

Manufacturer Narrative

(b)(4).The covidien service engineer (se) inspected the device and verified the reported issue.The se replaced the single board computer (sbc) printed circuit board (pcb).The se performed extended self-testing on the device and all tests passed.

• 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: 6219439
• MDR Text Key: 64031565
• Report Number: 2023050-2017-00006
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

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 PLUS
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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