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

Model Number	HT70M-SY-EU
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator's touchscreen was not working.Patient involvement information was not provided by the customer.Repair will be completed at a non-medtronic location and the product is not in medtronic control.The reported complaint could not be confirmed without the product return.The complaint will be closed and reopened/updated should new information become available or if the product is returned to the manufacturer for investigation.The information has been added to the database for trending purposes and trends will continue to be monitored.A capa is not required at this time.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ventilator's touchscreen was not working.Patient involvement information was not provided by the customer.The repair was completed at a non-medtronic location.The service provider (sp) cross checked the touchscreen and found it to be in working condition.The reported complaint could not be confirmed without the product return.

• 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: 6407869
• Report Number: 2023050-2017-05072
• Device Sequence Number: 19031980
• Product Code: CBK
• UDI-Device Identifier: 10884521542105
• UDI-Public: 10884521542105
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/19/2017

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: HT70M-SY-EU
• Device Catalogue Number: HT70M-SY-EU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1