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

Model Number	HT70 PLUS
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4):failure investigation performed by (b)(6) on (b)(6) 2017: one main control board (p/n: gr-pcb3252a, s/n: (b)(4)) for the newport ht70 ventilator was received in fi.The reported symptom was verified.The main control board was placed in a known-good fi test unit.When connecting the emergency backup battery to the j8 connector of the control board, the device immediately powered on.When powering the unit off, the unit froze on the shut-down screen.The unit alarmed and spontaneously power cycled.After further inspection of the main control board, it was observed that q57 had signs of damage, as shown in the attached image.Using the diode tester function of the fluke 87 v true rms multimeter (id: (b)(4)), transistor q55 was determined to be shorted.Q57 and q55 are connected the emergency backup battery input to the enable pin of the switching regulator (u107) of the power selection circuit.Damage to these transistors would cause the reported symptom to occur.The root cause of the reported symptom was that q57 was damaged and q55 was shorted.The main control board was scrapped after the investigation.
Event or Problem Description
It was reported that after connecting the power cable to the ht70 ventilator, the alarm sounds when the power is turned off.Service engineer evaluated the device, found the main printed circuit board (pcb) was faulty, replaced the main pcb and the ventilator worked properly.This was a failure out of box (foob).There was no patient involvement.
Additional Manufacturer Narrative
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: 6580016
• Report Number: 2023050-2017-05317
• Device Sequence Number: 1123443
• 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,Followup
• Report Date (Section B): 04/24/2017

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?: No
• 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: 04/24/2017
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1