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

Model Number	HT70
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/18/2016
Type of Reportable Event	Death
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
The litigation complaint provided to medtronic on august 23, 2018 reported that on or about (b)(6) 2016, a patient at (b)(6) was using a medtronic ht70 ventilator and the patient¿s endotracheal tube became dislodged.It was further reported that the patient went into hypoxic ischemic encephalopathy, was transferred to (b)(6) and passed away on (b)(6) 2016.The ventilator has not been provided to medtronic for evaluation.Although there is no allegation of the product malfunctioning, this event is being conservatively reported due to a patient death.
Additional Manufacturer Narrative
The ventilator was not returned for evaluation; however, an inspection was performed via a third party.The ventilator passed all tests, determined to be fully functional, and remains in use.It was also noted that per the event logs, on the date of the incident (b)(6) 2016), there was no system failure and no automatic reset.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; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7871189
• Report Number: 2023050-2018-00065
• Device Sequence Number: 16629012
• Product Code: CBK
• UDI-Device Identifier: 10884521544062
• UDI-Public: 10884521544062
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HT70
• Device Catalogue Number: HT70M-WW-NA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death