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

Model Number	HT70
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after installation of a new air/oxygen mixer the ht70 ventilator the oxygen would only to up to 70%.There was no patient involvement at the time of the reported condition.
Additional Manufacturer Narrative
Product analysis #(b)(4): unit received for complaint of low readings is verified.Found that the mixer reads low throughout testing, well below the 70% complaint.Mixer was attached to a test ht70 and a calibrated pts2000 (id: (b)(4)) set to measure oxygen and allowed to cycle under standard test settings.When the mixer is set at 21 the ht70 reads 21 and the pts reads 20.9, when set at 50 the ht70 reads 23 and the pts reads 22.8, when set at 100 the ht70 reads 37 and the pts reads 36.The mixer was disassembled for internal inspection.Found dirty filter.Found dirty diaphragm.The root cause of the low readings could not be determined and there were no other anomalies observed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that after installation of a new air/oxygen mixer the ht70 ventilator the oxygen would only to up to 70%.There was no patient involvement at the time of the reported condition.

• 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: 6623405
• Report Number: 2023050-2017-05444
• Device Sequence Number: 738893
• Product Code: CBK
• UDI-Device Identifier: 10884521542334
• UDI-Public: 10884521542334
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K090888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: HT70
• Device Catalogue Number: MXL70A-GR-DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 06/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1