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

Model Number	HT70
Medical Device Problem Codes	No Audible Alarm (1019); Alarm Not Visible (1022)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation but still the repair is pending.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ht70 ventilator experienced a system error and device alert with no audible or visual alarms.The ventilator was not in use on a patient at the time of the reported event. .
Additional Manufacturer Narrative
The single board computer (sbc) was received by failure investigations for analysis.The component was attached to the failure investigation test ventilator.The ventilator powered up.The logs were downloaded and reviewed.The issue was confirmed via logs.A test circuit and lung were connected to the ventilator and was allowed to ventilate for a week.There were no errors observed.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): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7457178
• Report Number: 2023050-2018-00026
• Device Sequence Number: 11133477
• Product Code: CBK
• UDI-Device Identifier: 10884521542143
• UDI-Public: 10884521542143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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
• Device Catalogue Number: HT70M-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1