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

Model Number HT70

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the engineer evaluated the ventilator and replaced the pump.The ventilator passed all testing per the service manual specifications and was returned to the customer for clinical use.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during use on a patient the ht70 ventilator has generated an " motor error alarm" and stopped ventilation.Patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.

Manufacturer Narrative

Device evaluation summary: one pump/manifold assembly was received by failure investigations for analysis.The issue of a motor error alarm was not confirmed; however, an alternate failure was observed.The pump had debris in the pistons.This was caused by worn linear piston bearings.The event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HT70 VENTILATOR
• 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: 7567733
• MDR Text Key: 110036926
• Report Number: 2023050-2018-00031
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521542198
• UDI-Public: 10884521542198
• Combination Product (y/n): N
• PMA/PMN Number: K111146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• 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-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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