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).The service engineer (se) evaluated the ventilator and verified the reported malfunction.The unit failed the power on self-test (post), and the system would not load the parameters or settings.The se tried to reset the system and it would not power off or reset.A software reload was unsuccessfully attempted.The single board computer (sbc) printed circuit board assembly (pcba) was removed and replaced.The ventilator then passed all tests, calibrations and was found to be operating within manufacturing specifications.

Event Description

It was reported that a ventilator display became stuck on the start-up screen.There was no patient involvement.

Manufacturer Narrative

Product analysis: a single board computer (sbc) printed circuit board (pcb) was returned to covidien/ medtronic¿s product analysis.The returned component was installed into a test ventilator for analysis; functionality test was performed.An investigation was performed and the product analysis technician reported that the reported issue was duplicated; the root cause was isolated to a component (u700) on the pcb.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 avenue; costa mesa CA 92626
• Manufacturer (Section G): NEWPORT MEDICAL INSTRUMENTS, INC.; 1620 sunflower avenue; costa mesa CA 92626
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5213884
• MDR Text Key: 31085687
• Report Number: 2023050-2015-00316
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: HT70 PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: 12/17/2015
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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