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

Model Number HT70

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the engineer evaluated the ventilator and found that the ventilator does not alarm at power down.Ac power was connected.Unit was powered up into diagnostic mode.The input menu showed that the alarm silence button was stuck on high signal, indicating a short.The down arrow was found not to function, and alarm silence led was illuminated.The fault was isolated to the top membrane.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the ht70 ventilator down arrow key was not working and additionally found alarm silence light-emitting diode (led) would come on automatically.The ventilator was not in use on a patient at the time of the reported event. .

• Brand Name: HT70
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7856456
• MDR Text Key: 119647025
• Report Number: 2023050-2018-00063
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521542266
• UDI-Public: 10884521542266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2018

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
• Device Operator: Health Professional
• Device Model Number: HT70
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1