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

Model Number HT70

Device Problems Defective Alarm (1014); No Audible Alarm (1019); Device Sensing Problem (2917)

Patient Problem No Code Available (3191)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during use, the screen froze and the ventilator became inoperative.Additionally, when an alarm was triggered, the led on the handle was lit but there was no sound or message.The device continued ventilating but the patient was transferred to another ventilator.After rebooting the ventilator, the condition was not reproduced.

Manufacturer Narrative

Device evaluation summary: a check of the log information that indicated the state of the relevant device when the event occurred revealed no particular records indicating a device abnormality.Service engineer evaluated the device and was unable to duplicate the reported issue.The ventilator passed all testing and was returned to the customer.The single computer board was replaced as a precaution.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional codes added to evaluation codes result and conclusion.Device evaluation summary: one sbc board was returned to medtronic for further analysis.The sbc board was seated into the main control board of a test ht70 ventilator.The ventilator was powered up and successfully completed the power on self test (post).After post, the touchscreen was observed to be unresponsive to user input.Further investigation isolated the fault to the touch screen controller u1302 on the single-board computer (sbc) board.No new formal investigation is required, the event will be included in trending and monitoring.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 7626278
• MDR Text Key: 111918110
• Report Number: 2023050-2018-00034
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521542075
• UDI-Public: 10884521542075
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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: HT70M-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1