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

Model Number	HT70
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ht70 ventilator that the o2 value was up to 10% when the setting at 60-80%.Patient involvement was not reported.
Additional Manufacturer Narrative
Additional information was received on 2017-jun-22.Device evaluation information was available at the time of the initial report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ht70 ventilator oxygen (o2) value was up to 10% when the setting was at 60-80%.The ventilator was not in use at the time of reported issue.A service engineer (se) inspected the device and replaced the mixer.The unit passed all testing and operated within the manufacturing specifications.

• 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: 6708164
• Report Number: 2023050-2017-05526
• Device Sequence Number: 16403583
• Product Code: CBK
• UDI-Device Identifier: 10884521542105
• UDI-Public: 10884521542105
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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,Followup
• Report Date (Section B): 06/15/2017

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-SY-EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1