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

Model Number HT70 PLUS

Device Problems Device Inoperable (1663); Low Battery (2584)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the ht70 ventilator generated a replace coin battery alarm.There was no patient involvement at the time of the reported condition.Technical support engineer (tse) troubleshot this issue with the customer over the phone.Customer is expected to have the unit repaired.

Manufacturer Narrative

Additional information was received by the customer that the ventilator was repaired by a third party service provider and is now back in service.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HT70 PLUS VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• 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 avenue; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6619799
• MDR Text Key: 76950173
• Report Number: 2023050-2017-05421
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

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: HT70PM-WW-NA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 06/06/2017
• Supplement Dates FDA Received: 11/15/2017
• Date Device Manufactured: 09/27/2013
• 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