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 Type  malfunction  

Manufacturer Narrative

(b)(4).Covidien was not authorized to evaluate/service the device so the reported complaint could not be confirmed.

Event Description

It was reported that at a time of maintenance the ht70 ventilator screen froze at the photo image.There was no patient involvement.

Manufacturer Narrative

Covidien reference number: (b)(4).The service engineer replaced the single board computer (sbc) printed circuit board (pcb) and the issue was resolved.The device was returned to use.

Manufacturer Narrative

Failure investigation performed by (b)(6) on (b)(6) 2017: 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 at a time of maintenance the ht70 ventilator screen froze at the photo image.There was no patient involvement.Covidien was not authorized to evaluate/service the device so the reported complaint could not be confirmed.

Manufacturer Narrative

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 and functionality testing was performed.An investigation was performed and the product analysis technician reported that the reported issue was verified.The root cause was isolated to software.If information is provided in the future, a supplemental report will be issued.

• 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 CA 92626
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6326887
• MDR Text Key: 67487526
• Report Number: 2023050-2017-00125
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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