MAUDE Adverse Event Report: RESMED LTD AIR 10 PSU 90W USA

Model Number 37344

Device Problem Arcing (2583)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported to resmed that the user's hand was burned due to arcing of the cord and splitting of the plug from the cord when the user plugged the power cord into the wall.

• Brand Name: AIR 10 PSU 90W USA
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: ariana beck ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 8613426
• MDR Text Key: 145221965
• Report Number: 3004604967-2019-00161
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 37344
• Device Catalogue Number: 37344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2019
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1