MAUDE Adverse Event Report: NEWPORT HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of evaluation will be submitted within a supplemental mdr upon completion of device evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ht70 ventilator had a cracked case and handle.There was no patient involvement with the reported event.Upon receiving the device for evaluation, it was observed that the silence button light was flashing intermittently and caused no audible alarm when the unit was turned off.
Additional Manufacturer Narrative
Device evaluation summary: one newport ht70 ventilator was returned for failure investigation.The customer reported symptom of a cracked handle and case was verified, but the reported symptoms of the alarm silence light-emitting diode (led) flickering and no audible shutdown alarm could not be duplicated.The ventilator successfully completed the power on self test (post).The unit under testing (uut) was powered up and successfully completed post.The alarm silence led did not flicker while the was powered on.The led was toggled on and off 30 times by pressing the alarm silence reset button.During each button press, the led was responsive.After shutdown, the piezoelectric buzzer sounded.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7926227
• Report Number: 2023050-2018-00067
• Device Sequence Number: 19281979
• Product Code: CBK
• UDI-Device Identifier: 10884521542143
• UDI-Public: 10884521542143
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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
• Device Catalogue Number: HT70M-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1