MAUDE Adverse Event Report: RESMED CORP. CPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 37207 AIR SERIES 10

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2019

Event Type  malfunction  

Event Description

Concern is regarding a resmed s10 cpap machine.I woke up to a smell similar to someone welding during the middle of the night.The water chamber had a scorched mark on the bottom of the interior where it sets on the heating element.The burning smell was from the water chamber where it had been scorched from the heating element overheating.The smell is in the interior of the machine and i haven't been able to get rid of it.I'm concerned that when the heating element scorched the chamber, it emitted toxins that have attached to the inside of the cpap machine.Machine is now unusable and unsafe due to the smell and potential health and fire hazard.Fda safety report id# (b)(4).

• Brand Name: CPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 8716952
• MDR Text Key: 148752573
• Report Number: MW5087476
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 37207 AIR SERIES 10
• Device Catalogue Number: DEVICE #743
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1