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

Model Number HT70P

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported when the ventilator was turned on, the screen got stuck, it did not go to the ventilation screen.There is no reported patient involvement associated with this event.

Manufacturer Narrative

(b)(4).The ventilator was returned for evaluation.The service engineer evaluated the device and could not verify the reported complaint.The device was tested and no failures were observed.The device passed all testing.The reported malfunction could not be duplicated.

Manufacturer Narrative

An investigation was performed and the technician found that the reported problem could not be duplicated.No failure was detected.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: 5220979
• MDR Text Key: 31317868
• Report Number: 2023050-2015-00313
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,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: HT70P
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided; 11/24/2015
• Supplement Dates FDA Received: 01/27/2016; 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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