MAUDE Adverse Event Report: RESMED CORP RESMED CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Temperature Problem (3022); Patient Device Interaction Problem (4001)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/06/2022

Event Type  Injury  

Event Description

The ac adaptor on my resmed cpap machine became so hot that it caused me to get a second degree burn on my shoulder.I had to go to urgent care.I had blistering.Looks like i will have a permanent scar.I had the cpap machine on my bedside table.The ac adapter was on the edge of my mattress.I must have rolled over on it when i was sleeping.On woke with a large burn on my shoulder.I have pictures.Fda safety report id# (b)(4).

• Brand Name: RESMED CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 14801247
• MDR Text Key: 294936431
• Report Number: MW5110493
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White