MAUDE Adverse Event Report: RESMED LTD LUMIS 150 VPAP ST FR

Model Number 28111

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that a patient using a lumis 150 device expired.There is insufficient information regarding the allegation of malfunction.It was reported the patient was hospitalized for respiratory problems, recovered and was expected to be discharged from the hospital the day after the date of death.

• Brand Name: LUMIS 150 VPAP ST FR
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8903913
• MDR Text Key: 154681383
• Report Number: 3004604967-2019-00265
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 28111
• Device Catalogue Number: 28111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/19/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death