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

Model Number HT70M-JP-NA

Device Problems Defective Alarm (1014); Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/17/2022

Event Type  malfunction  

Event Description

It was reported that while in use on a patient, the ht70 ventilator's alarm for airway pressure tube disconnection was repeatedly activated and released, but the alarm did not sound.The patient had difficulty breathing and the oxygen saturation was "lowering".The patient recovered after being placed on an alternate ventilator.It was identified from the logs that the ventilator generated an alarm but was cleared then silenced was activated by the user and reset was pressed.

Manufacturer Narrative

Patient identifier and initial reporter information cannot be provided due to the restriction by the japan privacy regulation.Medtronic affiliate reported on behalf of the customer.Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the ht70 ventilator's alarm for airway pressure tube disconnection was repeatedly activated and released, but the alarm did not sound.The unit was repaired by third-party service provider tokibo (tkb).One speaker cable assembly was received by medtronic for failure analysis.Inspection of the cable assembly found that it was covered in a foreign substance and the diaphragms had been damaged, allowing the speaker to move about freely in the housing.The speaker cable assembly was connected to test ventilator.It was found that due to the damage, excessive movement of the speakers could cause the audio to drop out.The cause of the event was isolated to faulty speaker cable assembly.A service history review was performed.The serial number indicates that the unit is more than 2 years old and there has not been any medtronic service performed within the past 2 years.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.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
• Manufacturer (Section G): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad; 7606035046
• MDR Report Key: 15053976
• MDR Text Key: 304715303
• Report Number: 2023050-2022-00019
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521542075
• UDI-Public: 10884521542075
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2022

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: HT70M-JP-NA
• Device Catalogue Number: HT70M-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2012
• 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