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

Model Number	HT70
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
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 had a low fraction of inspired oxygen (fio2).Patient involvement information was not provided by the customer.Covidien/medtronic was not authorized to evaluate/service the device so the reported complaint could not be confirmed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The ventilator was not in use on a patient at the time of the reported event.

• 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: 6648290
• Report Number: 2023050-2017-05480
• Device Sequence Number: 16414549
• 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: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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?: No
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1