MAUDE Adverse Event Report: NEWPORT NEWPORT HT70 VENTILATOR PLUS MODEL

Model Number HT70

Device Problems Defective Alarm (1014); Disconnection (1171)

Patient Problem Death (1802)

Event Date 07/03/2017

Event Type  Death  

Event Description

Resident found unresponsive in her bed on (b)(6) 2017 at approximately 8:00 pm.Staff reports the machine was still attempting to ventilate and vibrating only even though disconnected.No auditory alarm sounded.

• Brand Name: NEWPORT HT70 VENTILATOR PLUS MODEL
• Type of Device: NEWPORT HT70 VENTILATOR
• Manufacturer (Section D): NEWPORT ; 1620 sunflower ave.; costa mesa CA 92626
• MDR Report Key: 7499807
• MDR Text Key: 107833900
• Report Number: 7499807
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HT70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/03/2017
• Event Location: Nursing Home
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Weight: 103