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

Model Number	HT70
Medical Device Problem Codes	Smoking (1585); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the service engineer evaluated the ventilator, verified the reported event and replaced top membrane and right membrane.During calibrations, the unit began to smoke because of a suspected electrical short.The service engineer replaced the internal battery and main control board.Upon further investigation, the relief valve solenoid cabling was discovered to be damaged and had shorted the replaced control board as it did the original control board.After replacing the main control board and relief valve solenoid, the ventilator passed all testing per manufacturing specifications and was placed back into clinical use.If the replaced part is returned for failure investigation, a supplemental medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ht70 ventilator¿s alarm silence reset button and led (light-emitting diode) were not functioning.
Additional Manufacturer Narrative
Device evaluation summary: one top membrane and right membrane were returned to medtronic for further analysis.The ribbon cable connector was severed from the remaining membrane.The membranes were likely damaged during removal from unit.The severed ribbon cable connector will likely make the keyboard inoperable.Two main control boards were returned to medtronic for further analysis.A visual inspection of the returned board shows transistor q41 was observed to be damaged.According to the main control board schematic diagram, this transistor is connected to the relief valve connector (j39).As the reported symptom of shorting of boards for the valve could not be duplicated, the root cause of the damaged q41 could not be determined.One solenoid relief valve was returned to medtronic for further analysis.A visual inspection of the returned part shows damage to the cable insulation.The solenoid valve was installed into the failure investigation (f.I) test bed and it successfully passed post.The valve tested satisfactorily.The exposure of the cable insulation will likely cause the shorting of the board, however without the actual orientation of the cables in the original ventilator, a cause could not be established.One emergency backup battery was returned to medtronic for further analysis.The battery was installed into the failure investigation (f.I) test ventilator and it successfully passed all tests and calibrations.The battery tested satisfactorily.The likely cause of the reported event was isolated to the damaged ribbon cable connector, but without the actual condition of the cable in the field, a cause could not be determined.The likely cause of the secondary finding (smoke) is due to the damaged insulated solenoid cable.The event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 8855716
• Report Number: 2023050-2019-00032
• Device Sequence Number: 2397263
• Product Code: CBK
• UDI-Device Identifier: 10884521542259
• UDI-Public: 10884521542259
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2019

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: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1