MAUDE Adverse Event Report: RESMED LTD LUMIS 100 VPAP ST EUR2; Ventilator, continuous, non-life-supporting

Model Number 28306

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.The lumis 100 vpap st user guide provides the following indications for use: - ¿the lumis 100 vpap st device is indicated to provide non-invasive ventilation for patients weighing more than 13 kg with respiratory insufficiency or obstructive sleep apnea (osa).It is intended for home and hospital use.¿ it is only intended to provide ventilation to a spontaneously breathing patient as it is not a life support ventilator.The user guide also provides the following warning: - ¿the device is not suitable for ventilator dependent patients.¿ resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient receiving therapy from a lumis 100 vpap st device was found expired with the device powered off.

Event Description

It was reported to resmed that a patient receiving therapy from a lumis 100 vpap st device was found expired with the device powered off.

Manufacturer Narrative

The lumis device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Review of the device data logs revealed on the day of the reported event, smart start function was disabled which requires initiation of therapy by manually pressing the start button.The lumis 100 vpap st user guide provides the following indications for use: ¿the lumis 100 vpap st device is indicated to provide non-invasive ventilation for patients weighing more than 13 kg with respiratory insufficiency or obstructive sleep apnea (osa).It is intended for home and hospital use.¿ it is only intended to provide ventilation to a spontaneously breathing patient as it is not a life support ventilator.The user guide also provides the following warning: ¿the device is not suitable for ventilator dependent patients.¿ resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

• Brand Name: LUMIS 100 VPAP ST EUR2
• Type of Device: Ventilator, continuous, non-life-supporting
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 15080747
• MDR Text Key: 296367924
• Report Number: 3007573469-2022-00490
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 10/25/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 28306
• Device Catalogue Number: 28306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2022
• Distributor Facility Aware Date: 09/29/2022
• Device Age: 33 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 63 KG