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

Model Number	HT70
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 blender leaked when it was connected to the oxygen source.There was no patient involvement at the time of the reported condition.
Additional Manufacturer Narrative
Correction: corrected catalog # to h70; serial #: unknown; (b)(6).The serial number of the ventilator was not provided therefore the device manufacture date is unknown.Device evaluation: the blender mixer was returned to medtronic¿s failure analysis laboratory.An investigation was performed and the reported issue could not be verified.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ht70 ventilator blender leaked when it was connected to the oxygen source.There was no patient involvement at the time of the reported condition.The customer was to be provided a replacement blender.

• 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: 6648851
• Report Number: 2023050-2017-05483
• Device Sequence Number: 953722
• Product Code: CBK
• UDI-Device Identifier: 10884521542334
• UDI-Public: 10884521542334
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K090888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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: HT70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1