MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC. E500 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number E500

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2017

Event Type  malfunction  

Event Description

It was reported that a e500 ventilator was emitting burning smell.The ventilator was not on a patient at the time of the event.Medtronic was not authorized to evaluate/service the device so the reported complaint could not be confirmed.

Manufacturer Narrative

A battery and a power supply were returned to covidien/medtronic¿s product analysis.A visual inspection found no notable conditions on the battery, the power supply had a trace on the back of the printed circuit board (pcb) that was burned through and a trace showed bare copper.The product analysis technician reported that there was slight smoking odor observed on the pcb.An investigation was performed and the product analysis technician reported that no fault was found on the battery.The power supply cause of the damage could not be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: E500 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: ray maroofian ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6517971
• MDR Text Key: 73564124
• Report Number: 2023050-2017-05211
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E500
• Device Catalogue Number: E500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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