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	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: an ht70 ventilator was returned to covidien/ medtronic for failure analysis.During quick check the buzzer failed.The unit was disassembled and the cable was found to be damaged and was observed that no alarms were generated when the unit was turned off.The cable was replaced and the ventilator pass all testing.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 broken case and was being sent back for preventative maintenance (pm).The buzzer alarm was working at the time of the estimate to the customer.After the repair were performed the service the engineer checked the ventilator and found that the buzzer was not alarming when the unit was turned off.The ventilator was not in use on a patient at the time of the reported event.

• 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: 7535246
• Report Number: 2023050-2018-00030
• Device Sequence Number: 10999220
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: 04/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1