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

Model Number	HT70PM-JP-NA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that while in use on a patient, the nurse found that the ht70 ventilator shut down alarm suddenly generated and the screen had already been blacked out.The sound was turned off with mute and restarted the ventilator but had no response.The patient was removed from the ventilator and placed on an alternate ventilator without harm.
Additional Manufacturer Narrative
Correction to section h6.Evaluation codes method, result and conclusion.H3: device evaluation summary: it was reported that third party service provider tokibo (tkb) repaired the unit by replacing control board.The unit was in working condition.Medtronic conducted an investigation based upon all information received.The device was/was not available for evaluation.One ht70 control board was received for failure analysis.The sound was turned off with mute and restarted the ventilator but had no response.The power could not be turned on and ventilation stopped.The device was unable to power on with either battery alone or external power.The control board was removed and was further inspected.Capacitor c92 was found to be shorted and visually cracked.A known good component was harvested from another board and was soldered in place of the shorted capacitor.The device was then able to power on properly.The device then ventilated at standard test settings as per the service manual for approximately 48 hours, during this time the device functioned properly.No other errors were detected; the reported symptom of stopped ventilation could not be replicated once the capacitor was replaced.The control board and capacitor have been retained by failure investigations.The cause of the event was determined to the faulty component capacitor c92 to be shorted and visually cracked in control board.The event is included in trending and monitoring plan.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.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
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 9889835
• Report Number: 2023050-2020-00010
• Device Sequence Number: 16882002
• Product Code: CBK
• UDI-Device Identifier: 10884521542198
• UDI-Public: 10884521542198
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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
• Operator of Device: Health Professional
• Device Model Number: HT70PM-JP-NA
• Device Catalogue Number: HT70PM-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1