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

Model Number	HT70 PLUS
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/05/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4): failure investigation performed on 04/14/2017 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.After powering the unit on, the unit froze on the six image screen.This complaint is in scope of capa (b)(4).Software was released in response to this issue.Additional failure investigation is not required.Since this was a mdr investigation the sbc board was retained for further analysis if deemed necessary.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information stating during set up the ht70 ventilator cannot complete the boot up process.The display froze and the ventilator was unable to shut off.The machine could only be shut off after the battery was empty.The software was upgraded but it did not resolve the issue.The single board computer needs to be replaced.This was a failure out of box (foob).There was no patient involvement.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The suspect component was returned to covidien/ medtronic¿s product analysis. a visual inspection of the returned component was performed.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician reported that the reported issue was verified.The identified root cause of the reported issue was isolated to interface between the device and the failed component.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HT70 PLUS VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENTS INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 6579582
• Report Number: 2023050-2017-05316
• Device Sequence Number: 19090784
• Product Code: CBK
• UDI-Device Identifier: 10884521542228
• UDI-Public: 10884521542228
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2017

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
• Operator of Device: Health Professional
• Device Model Number: HT70 PLUS
• Device Catalogue Number: HT70PM-SY-EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 04/24/2017; 04/24/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 10/04/2017; 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1