MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC E360 VENTILATOR; CONTINUOUS VENTILATOR

Model Number E360

Device Problems Premature Discharge of Battery (1057); Failure to Charge (1085)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was replaced.Covidien was not authorized to evaluate/repair the device.

Event Description

It was reported that during use the e360 ventilator battery indicator showed only 2 bars from the first.The patient was transferred to a different ventilator.There was no patient harm/injury reported as a result of this event.

Manufacturer Narrative

(b)(4).The service engineer (se) inspected the device and verified the reported issue.The se replaced the battery and the ventilator was returned to use.

Manufacturer Narrative

Unique identifier (udi) number added to additional codes added to patient and device codes, evaluation codes result and conclusion.Corrections contact information.Pma / 510k #.Device evaluation summary: the battery was returned to medtronic for failure investigation.The battery was connected to uba battery analyzer.The voltage was too low to start the test protocol.The battery was allowed to trickle charge for two days.The voltage did not rise above 5.8 vdc.Due to the extensive length of time between the reported date of the complaint and the return of the battery, it is unable to be determined if the battery was actually faulty at the time of complaint.Unable to determine customer complaint that battery only showed two bars of charge.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: E360 VENTILATOR
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENTS, INC; 1620 sunflower ave.; costa mesa CA 92626
• MDR Report Key: 6205117
• MDR Text Key: 63305692
• Report Number: 2023050-2016-00791
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K101803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E360
• Device Catalogue Number: E360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention