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

Model Number	HT70
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during start up the ht70 ventilator alarm generated a " date has reset please replace coin battery" message.There was no patient involvement.The service engineer replaced the coin battery and the control printed circuit board.The ventilator was found to be in working condition.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENTS, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 6753142
• Report Number: 2023050-2017-05583
• Device Sequence Number: 11009278
• Product Code: CBK
• UDI-Device Identifier: 10884521542044
• UDI-Public: 10884521542044
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2017

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: HT70M-CN-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1