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

Model Number	HT70 PLUS
Medical Device Problem Code	Failure to Pump (1502)
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 during preventative maintenance, the ht70 plus ventilator pump was not working properly.There was no patient involvement at the time of the event.The service engineer evaluated the ventilator and replaced the pump and manifold assembly.The ventilator passed all testing.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The ventilator was returned to the service center where the pump and manifold assembly was replaced and preventative maintenance was performed which was due or overdue.The ventilator passed all testing.
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.
Additional Manufacturer Narrative
Update to evaluation code result.Device evaluation summary: the pump/maniford assembly was received by failure investigations for analysis.The issue was confirmed.The complaint was isolated to a leak and the probable cause a missing o-ring.No corrective action is required, because no trend has been identified.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HT70 PLUS 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: 6792072
• Report Number: 8020893-2017-07419
• Device Sequence Number: 1038674
• Product Code: CBK
• UDI-Device Identifier: 10884521542228
• UDI-Public: 10884521542228
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K111146
• 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,Followup,Followup
• Report Date (Section B): 06/25/2018

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 PLUS
• Device Catalogue Number: HT70PM-SY-EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 10/31/2017; 10/31/2017; 06/14/2018
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 10/31/2017; 10/31/2017; 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1