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

Model Number	HT70 PLUS
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Service personnel (sp) inspected the ventilator and confirm the noisy ventilator event.Sp reported that pump was replaced to solve the issue.Ventilator passed all test and calibrations per manufacturer specifications at the time of service.One pump was returned to medtronic for further analysis.A visual inspection of the returned board shows no anomalies.The pump was attached to the failure investigation (f.I) test ventilator and it initially made a chattering noise and then locked up.The unit under testing was powered down and the pump was removed and inspected.On the small cap end of the pump, there was a significant amount of metal shavings and black debris observed within the linkage cover.Upon further inspection, the axle on the linkage to the linear bearing was loose within the linkage arm's radial bearing.The cause of the noisy pump was by a worn linkage arm radial bearing on the small cap end of the pump.The event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ht70 ventilator had a blank display.Additionally, it was noted that the pump was noisy.The ventilator was not in use on a patient at the time of the reported event. .

• Brand Name: HT70 PLUS 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: 8857941
• Report Number: 2023050-2019-00033
• Device Sequence Number: 2361593
• Product Code: CBK
• UDI-Device Identifier: 10884521542266
• UDI-Public: 10884521542266
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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 PLUS
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1