MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC. NEWPORT; CONTINUOUS VENTILATOR

Model Number HT70

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The ventilator returned for two year preventive maintenance as well as having the printed circuit board replaced to resolve the reported issue of the unit stopping at the screen.

Event Description

It was reported that when the ventilator was turned on, the screen got stuck on the screen.Although requested, no information regarding patient involvement has been provided.

Manufacturer Narrative

The device was repaired and 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: NEWPORT
• 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: 5183392
• MDR Text Key: 30221096
• Report Number: 2023050-2015-00289
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K090888
• 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: 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
• Device Operator: No Information
• Device Model Number: HT70
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: 10/01/2015
• Supplement Dates FDA Received: 12/20/2017
• 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