MAUDE Adverse Event Report: RESMED LTD SLEEPMATE 10 AUTO

Model Number 37418

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 08/03/2020

Event Type  Injury  

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 receiving therapy via sleepmate 10 device was admitted to the hospital for right lung pneumothorax, underwent surgery and was discharged.The patient¿s doctor reported it is possible that the weakened area of the patient¿s lung due to cancer was torn by the positive pressure of cpap therapy.There was no reported allegation of device malfunction.

• Brand Name: SLEEPMATE 10 AUTO
• 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: 10588094
• MDR Text Key: 208593711
• Report Number: 3004604967-2020-00931
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JP
• PMA/PMN Number: K140124
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37418
• Device Catalogue Number: 37418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/28/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80