MAUDE Adverse Event Report: RESPIRONICS CPAP MODEL M-SERIES HEATED HUMIDIFIER-DOM

Model Number 1051158

Device Problems Device Emits Odor (1425); Device Inoperable (1663)

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

Event Date 03/01/2016

Event Type  Injury  

Event Description

My resmed cpap machine model no.M-series heated humidifier - dom; model #: 1051158; serial number (b)(4) is smelling like something is burning.No smoke visible but the smell lingers when the machine is used then turned off.Heated humidifier does not work.I followed all instructions and maintenance, but it not right.How can i get a free replacement of this machine that will not have this effect?.

• Brand Name: CPAP MODEL M-SERIES HEATED HUMIDIFIER-DOM
• Type of Device: CPAP
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 5503830
• MDR Text Key: 40544091
• Report Number: MW5060917
• Device Sequence Number: 1
• Product Code: BTT
• 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: 03/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1051158
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 100