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 Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during testing, a ventilator was shut down and turned back on, upon which the screen got stuck.There was no patient involvement.

Manufacturer Narrative

(b)(4).Medtronic was not authorized to evaluate/service the device, so the reported complaint could not be confirmed and the repair could not be verified.A non-medtronic service provider returned a single board computer printed circuit board (pcb).The service engineer evaluated the pcb and could not verify the reported complaint.When the pcb was placed into a test ventilator the ventilator display remained black.The unit was power cycled several times with the same result.The reported event could not be duplicated.

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
• 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: 5110737
• MDR Text Key: 27107997
• Report Number: 2023050-2015-00241
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 12/21/2017

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: 09/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided; 08/23/2016
• Supplement Dates FDA Received: 08/26/2016; 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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