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

Model Number	HT70PM-SY-EU
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, before installing in hospital (customer site), while doing operational test, the ht70 generated an abnormal noise there was no patient involvement at the time of the reported condition.

• Brand Name: HT70 PLUS
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENTS INC.; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 6607890
• Report Number: 2023050-2017-05371
• Device Sequence Number: 1391310
• Product Code: CBK
• UDI-Device Identifier: 10884521542228
• UDI-Public: 10884521542228
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111146
• 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
• Report Date (Section B): 05/11/2017

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: HT70PM-SY-EU
• Device Catalogue Number: HT70PM-SY-EU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1