MAUDE Adverse Event Report: COSTA MESA MFG DC HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70
Medical Device Problem Codes	Mechanical Problem (1384); No Flow (2991)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One newport ht70 ventilator was returned to medtronic for analysis.The ventilator was powered up and when the ventilation was initiated, the motor locked up and the ventilator shut down.After power cycling the ventilator, the device froze on the 6-image screen.The cause of the frozen screen was a flash memory error.On further inspection, the muffler was observed to be cracked and the linear bearings were observed to be worn.The linkage arm was observed to be in contact with the plastic linkage cover, causing the motor to lock up.The root cause of the motor lock up was worn linear piston bearings.Service personnel (sp) reported that the pump assembly and muffler were replaced along with the air intake filter, fan filter, emergency backup internal battery, power pac and oxygen sensor.The ventilator passed all tests and calibrations per manufacturer specifications at the time of service.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
While servicing the ht70 ventilator, the ventilator displayed ¿date has reset please replace coin battery¿ message.It was additionally noted that the touchscreen was unresponsive.The coin battery was replaced, and circuit check was initiated.However, the ventilator failed the circuit check, stopped ventilating, and shut off.The ventilator powered cycled itself but then froze on the six-image screen.There was no patient involvement with the reported event.Based on the product analysis findings this event was updated to reportable.If this type of fault identified were to occur while in use on a patient it could lead to a loss of ventilation.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 8683624
• Report Number: 2023050-2019-00021
• Device Sequence Number: 19375344
• Product Code: CBK
• UDI-Device Identifier: 10884521542266
• UDI-Public: 10884521542266
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1