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

Model Number	HT70
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was requested but not provided by customer.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 during use on a patient, ht70 ventilator stopped ventilating.The patient was removed from the ventilator and placed on an alternate ventilator.There was no harm to the patient.
Additional Manufacturer Narrative
Device evaluation summary: the ht70 ventilator was returned for failure investigation.The reported symptom could not be duplicated, but a different symptom was observed.The ventilator was powered up and successfully completed the power on self test.The log files were exported.After reviewing the event history, all "power up" events were preceded by "power down" events, indicating that the device did not reset during operation.The device was allowed to ventilate for approximately 5 days.Throughout the duration of ventilation, all 4 measured signals remained stable and did not attenuate.No errors or alarms were observed.However, during operation, the pump was observed to emit a squeaking sound.Upon further inspection of the pump, no damaged piston bearings or debris was observed.The abnormal sound was likely to be caused by a check valve not being seated properly.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: service engineer evaluated the device and was unable to duplicate the reported issue.Unit was put into ventilation under received settings and no defect was found.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.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: 7993402
• Report Number: 2023050-2018-00072
• Device Sequence Number: 13873533
• Product Code: CBK
• UDI-Device Identifier: 10884521542266
• UDI-Public: 10884521542266
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/27/2018

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: HT70
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 10/06/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 11/26/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 11/19/2018; 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1