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

Model Number HT70

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 06/13/2018

Event Type  malfunction  

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 Description

It was reported that during use on a patient, the ventilator became inoperative.The patient was removed from the ventilator and placed on an alternate ventilator with no patient harm.

Manufacturer Narrative

Device evaluation summary: one newport ht70 ventilator was received for failure analysis.A reset during ventilation was verified in the error logs, but the reported symptom could not be duplicated.A different symptom of a bad block in the flash memory was observed.It is recommended that the single board computer (sbc) board is replaced.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HT70 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): NEWPORT; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7659621
• MDR Text Key: 113174760
• Report Number: 2023050-2018-00040
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521542198
• UDI-Public: 10884521542198
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HT70
• Device Catalogue Number: HT70PM-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1