MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENT, INC HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number HT70

Device Problems Defective Alarm (1014); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Covidien/medtronic has not received the device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during servicing observed the ht70 ventilator failed to alarm.It was also noted that the device was unable to upgrade.The ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

Device evaluation summary: service person checked the ventilator and found that the ventilator did not power up.Re-installed the software, calibration and performance verification test were completed successfully; unit passed all the tests and was working fine.The cause of the observed condition could not be determined as the reinstall of the software did resolved the reported issue, exact root cause could not be determined.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.

Event Description

Correction: it was observed that during servicing the ht70 ventilator failed post (power on self-test) and was unable to power on.The ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

Correction: (description event problem) (device codes).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): NEWPORT MEDICAL INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 9071051
• MDR Text Key: 162530211
• Report Number: 2023050-2019-00039
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521542266
• UDI-Public: 10884521542266
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• 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: 08/20/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1