MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC HT70 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 Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medtronic was not authorized to evaluate/service the device.A non-medtronic service provider turned the device off, restarted it and the display froze at the noted location.

Event Description

It was reported that the ht70 ventilator display froze at the six picture screen.There was no patient involvement.

Manufacturer Narrative

Product analysis #(b)(4) :failure investigation performed by (b)(6): one sbc board (p/n: pcb3207a, s/n: (b)(4)) for the newport ht70 ventilator was received in fi.The reported symptom was verified.The sbc board was placed in a known-good ht70 test bed and the device was powered on.The device froze on the 6-image display.This complaint is in scope of capa (b)(4).Software was released in response to this issue.Additional failure investigation is not required.The sbc board was scrapped after the investigation.

Event Description

It was reported that the ht70 ventilator display froze at the six picture screen.There was no patient involvement.Medtronic was not authorized to evaluate/service the device.A non-medtronic service provider turned the device off, restarted it and the display froze at the noted location.

• Brand Name: HT70 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
• Manufacturer Contact: ray maroofian ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6093106
• MDR Text Key: 59979487
• Report Number: 2023050-2016-00680
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• 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: HT70M-JP-NA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• 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