MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC HT50 VENTILATOR; CONTINUOUS VENTILATOR

Model Number HT50

Device Problems Device Alarm System (1012); Premature Discharge of Battery (1057)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Covidien reference number: (b)(4).An authorized third party service engineer replaced the battery.Ventilator has been returned to use.

Event Description

It was reported that a ventilator battery would not hold a charge and generated an alarm.The device worked as expected while on alternating current (ac) power.The device continued ventilating/cycling.The patient was removed from the ventilator and transferred to a different ventilator.There was no negative patient outcome (harm/injury) reported as a result of this event.

• Brand Name: HT50 VENTILATOR
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENTS, INC; 1620 sunflower ave.; costa mesa CA 92626
• Manufacturer (Section G): NEWPORT MEDICAL INSTRUMENTS, INC; 1620 sunflower ave.; costa mesa CA 92626
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5448897
• MDR Text Key: 38633314
• Report Number: 2023050-2016-00101
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K082724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HT50
• Device Catalogue Number: HT50-H1-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 7