MAUDE Adverse Event Report: COSTA MESA MFG DC HT70; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70PM-WW-NA
Medical Device Problem Codes	Mechanical Problem (1384); 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 customer replaced the pump assembly, performed calibration and performance verification testing per the service manual.The unit passed all the tests.One pump/manifold assembly for the newport ht70 ventilator was received for failure analysis.The reported symptom could not be duplicated but a different symptom was observed.The subassembly was installed into an ht70 test bed.The unit under testing (uut) was powered up and successfully completed the power on self test (post).The device was set to standard test settings per the ht70 service manual and ventilation was initiated.During ventilation, no abnormal noise was observed, but the device issued a "low pressure" alarm.A circuit check was performed.The uut failed the circuit check.The pump was removed from the test bed and disassembled.During destructive analysis, three of the four inlet check valve were observed have a torn silicone component.This would have a caused a leak in the system, causing a circuit check failure.The reported symptom of an abnormal noise could not be duplicated, but a different symptom of a "low pressure" alarm was observed.The "low pressure" alarm was caused by a torn silicone component of the inlet check valves.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 generated a noise during ventilation.There was no patient involvement at the time of the event.

• Brand Name: HT70
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 9198444
• Report Number: 2023050-2019-00046
• Device Sequence Number: 16920931
• 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): 10/16/2019

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: HT70PM-WW-NA
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1