MAUDE Adverse Event Report: RESMED LTD AIRSENSE 11 AUTOSET USA TRI; Ventilator, non-continuous (respirator)

Model Number 39001

Device Problem Unintended Electrical Shock (4018)

Patient Problems Burn(s) (1757); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Pain (1994); Electric Shock (2554); Unspecified Heart Problem (4454)

Event Date 10/08/2022

Event Type  Injury  

Manufacturer Narrative

The airsense 11 device was returned to resmed.The investigation methods, results, and conclusions are not finalised at this stage.If further information becomes available, a supplementary report will be submitted.The airsense 11 user guide states the following warning: beware of electrocution: do not immerse the device, ac adaptor or power cord in water.Do not connect to power while the device is wet.Make sure that all parts are dry before plugging it in.If liquids are spilled into or onto the device, unplug the device and let the parts dry.The user guide also provide the following warning: discontinue use and contact your care provider or resmed service center if any of the following occur: device does not perform as usual.Device is making unusual sounds.Device is damaged.Resmed reference#: (b)(4).Pending investigation.

Event Description

It was reported to resmed that a patient was allegedly electrocuted by his airsense 11 device during use.The patient bore burn injuries.The patient sought medical attention in an emergency care unit.The patient is currently still experiencing pain in chest, heart issues and trouble swallowing following the incident.Further information about the patient¿s medical condition is not available to resmed.

Manufacturer Narrative

The airsense 11 was returned to resmed for investigation.Performance testing revealed the device passed all functional tests and the device was performing per specification.The investigation concluded there was no relationship between use of the device and the reported incident.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient was allegedly electrocuted by his airsense 11 device during use.The patient bore burn injuries.The patient sought medical attention in an emergency care unit.The patient is currently still experiencing pain in chest, heart issues and trouble swallowing following the incident.Further information about the patient¿s medical condition is not available to resmed.

• Brand Name: AIRSENSE 11 AUTOSET USA TRI
• Type of Device: Ventilator, non-continuous (respirator)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 15769394
• MDR Text Key: 303396766
• Report Number: 3007573469-2022-00753
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498390014
• UDI-Public: (01)00619498390014(10)1616759
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 39001
• Device Catalogue Number: 39001
• Device Lot Number: 1616759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Distributor Facility Aware Date: 03/21/2023
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 04/19/2023
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 180 KG