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

Model Number	HT70
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer could not duplicate the reported issue but different malfunction was observed.The engineer evaluated the ventilator and replaced the top membrane.After servicing, the ventilator passed all testing per manufacturer's specification and was returned to the customer.The down arrow key was unresponsive and alarm led (light emitting diode) did not toggle on/off when the alarm silence/ reset button was pressed and immediately shutdown buzzer was silenced.The fault was isolated to top membrane.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The biomedical engineer reported that prior to use the ht70 ventilator down arrow key was not functioning.Additionally, the service engineer evaluated the device and found the device had no audible alarm.The ventilator was not in use on a patient at the time of the reported event. .

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 8169856
• Report Number: 2023050-2018-00079
• Device Sequence Number: 1459124
• Product Code: CBK
• UDI-Device Identifier: 10884521542266
• UDI-Public: 10884521542266
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1