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

Model Number	HT70
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial regulatory report was submitted under remediation e2017032.Device evaluation: the o2 sensor cable and control board was returned for further product analysis.The oxygen sensor cable was received.The customer complaint of fio2 calibration failed was verified and duplicated.The sensor cable was put in a test vent unit.The unit did not recognized the fio2 and the calibration could not be performed.Visual inspection revealed that the connector of the cable had broken wire connections, which was the root cause of the unit not recognizing the fio2.The control board was received and a different symptom was observed for this subassembly.After a visual inspection of the board, several instances of physical damage were observed.The terminals of capacitor c25 were partially dislodged from the capacitor body.The plastic component of both the j26 and j42 connectors were broken.Additionally a portion of the main control board was grazed.The root cause of the observed symptom was misuse/handling.
Event or Problem Description
It was reported that the ht70 ventilator fraction of inspired oxygen (fio2) calibration failed.There was no patient involvement.

• 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: 7390353
• Report Number: 2023050-2018-00020
• Device Sequence Number: 194379
• Product Code: CBK
• UDI-Device Identifier: 10884521542105
• UDI-Public: 10884521542105
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 04/02/2018

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-SY-EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1