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

Model Number	HT0
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ht70 ventilator was returned for failure investigation.The unit under testing (uut) was powered and it initially successfully completed post (power on self test).After the unit under testing (uut) was powered down, the shutdown buzzer was immediately silenced.The unit under testing (uut) was disassembled and the top membrane was tested and inspected.This lower resistance indicated a short between the alarm silence and breathing indicator pin.At the end of a typical shutdown sequence, the breathing indicator led briefly illuminates.Therefore a short between the breathing indicator pin and the alarm silence pin would cause the buzzer to be silenced at the end of the shutdown sequence.The root cause of the reported symptom was that pins 2 and 3 of the top membrane were shorted.After a few power cycles, an additional symptom of the device freezing on the 6-image display was observed.The serial port of the device was connected to a computer with hyper terminal software.This was address and upgrading to new software version rectifies this issue.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 not generated an audible alarm when the device was shut down.The ventilator was not in use on a patient at the time of the reported event. .

• Brand Name: HT70
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7806608
• Report Number: 2023050-2018-00057
• Device Sequence Number: 1351019
• Product Code: CBK
• UDI-Device Identifier: 10884521542143
• UDI-Public: 10884521542143
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/22/2018

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: HT0
• Device Catalogue Number: HT70M-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1