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

Model Number HT70

Device Problem Loss of Power (1475)

Patient Problem Hypoventilation (1916)

Event Date 04/16/2019

Event Type  Injury  

Event Description

While ventilating pt with newport ht70 ventilator, the ventilator shutdown.Unit was restarted and performed normally after.Was this device serviced by a third party servicer? yes.Fda safety report id# (b)(4).

• Brand Name: NEWPORT HT70 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENTS INC.
• MDR Report Key: 8712404
• MDR Text Key: 148616344
• Report Number: MW5087454
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/14/2019

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
• Device Operator: Health Professional
• Device Model Number: HT70
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2019
• 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): Required Intervention
• Patient Age: 85 YR