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

Model Number	HT70
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the ht70 ventilator was returned to medtronic for failure investigation.The unit was received to service with no accessories.The unit powered on and passed the power on self test (post).The unit was put through testing and was observed to have an abnormal bearing noise.Unit was put into ventilation using received settings.Loud noise was observed coming from pump (bearing issue).The pump locked up and ceased ventilation then broke free.When the pump locked up it displays a battery alarm.No device alert was triggered during breath delivery when pump ceased ventilation.When pump ceased ventilation display was showing green icon to trigger breath and no output was observed.The unit was forwarded to failure analysis for further investigation.The symptom of the pump emitting a loud noise was verified, but the symptom of the pump locking up without alarm could not be duplicated.The unit was allowed to ventilate for approximately 4 days on the incoming settings.Throughout the duration of ventilation, the pump made a loud chattering sound.The pump did not lock up during ventilation.The pump was replaced.Additionally the 2 year preventative maintenance parts, air intake filter, fan filter, emergency backup internal battery, coin battery, power pace and oxygen sensor were replaced.The ventilator passed all testing per manufacturer's specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ht70 ventilator was unable to calibrate oxygen.There was no patient involvement with 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: 8401609
• Report Number: 2023050-2019-00009
• Device Sequence Number: 2326613
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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: HT70
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1