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

Model Number	HT70PM-SY-EU
Medical Device Problem Codes	No Flow (2991); Power Problem (3010)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
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, an ht70 ventilator shut down.Although requested, the patient treatment and outcome is unknown.
Additional Manufacturer Narrative
Additional information in section a correction.B5 correction.H6 patient and device codes.Additional information regarding repair as follows: medtronic conducted an investigation based upon all information received.The ventilator was evaluated and checked by a third party, and found that the ht70 ventilator shutdown related to the battery.The device was not returned for evaluation.An associated device issue could not be confirmed.Failure confirmation, root cause, or relationship to the event could not be determined since no product was returned for evaluation or made available to medtronic.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that the product 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.
Event or Problem Description
Received clarification from the initial reporter stating that the reported event occurred during demonstration of the ht70 ventilator and there was no patient involvement at the time of reported event.

• Brand Name: NEWPORT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 9470041
• Report Number: 2023050-2019-00051
• Device Sequence Number: 19608962
• Product Code: CBK
• UDI-Device Identifier: 10884521542228
• UDI-Public: 10884521542228
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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-SY-EU
• Device Catalogue Number: HT70PM-SY-EU
• Device Lot Number: HT70
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1