MAUDE Adverse Event Report: COSTA MESA MFG DC NEWPORT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial regulatory report was submitted under retrospective summary report e2017032.Unique complaint identification number: (b)(4) device evaluation summary: the pump assembly was replaced.One pump/manifold assembly for the newport ht70 ventilator was received for failure analysis.The reported symptom was verified.The pump/manifold assembly was connected to the main control board and pneumatic circuit of an ht70 test unit.The unit under testing (uut) was powered up and allowed to ventilate on standards test settings per the ht70 service manual.During operation, the pump was making a chattering sound.The root cause of the reported symptom was worn radial bearings.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the 12 month check, the ht70 ventilator pump assembly was generating noise during ventilation.There was no patient involvement at the time of the event.

• Brand Name: NEWPORT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7787416
• Report Number: 2023050-2018-00054
• Device Sequence Number: 16659532
• Product Code: CBK
• UDI-Device Identifier: 10884521542266
• UDI-Public: 10884521542266
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/15/2018

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: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1