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

Model Number	HT70
Health Effect - Clinical Code	Death (1802)
Date of Event	06/16/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Covidien/medtronic has not received the device/component from the customer for evaluation nor has the field service engineer evaluated the ventilator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient expired while on ht70 ventilator.There is no allegation of a malfunction of the device.The customer is sending the ventilator for failure evaluation.This report is being conservatively filed only because the patient expired while using the ventilator.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: an ht70 ventilator was reported to be in use during patient exitus.There was no allegation of a malfunction of the device when it was reported to medtronic.The customer sent the ventilator to failure investigations (fi) for analysis.Since the reported symptom of the device was unspecified, it could neither be duplicated nor verified.Fi contacted the customer for more details; the customer stated that she was not there when the incident occurred, but she heard from the nurses that the vent alarmed and shut off during the event.The device logs were reviewed, and no recorded events were logged in the event history on the date of patient exitus.Fi found that the device failed the power on self-test.Fi found the cause of this to be an internal short, and fi replaced the main control board to address this.Fi also found that the pump made a grinding sound, and fi tightened loose hardware to address this as well.Although the patient presented exitus while on the ventilator, there is no evidence that the ventilator caused the patient exitus.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 INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7696592
• Report Number: 2023050-2018-00042
• Device Sequence Number: 1452397
• Product Code: CBK
• UDI-Device Identifier: 10884521542143
• UDI-Public: 10884521542143
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/08/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/30/2018
• 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