MAUDE Adverse Event Report: PHILIPS RESPIRONICS REMSTAR PRO

Model Number 450P

Device Problems Material Disintegration (1177); Device Emits Odor (1425); Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

Patient Problem Fibrosis (3167)

Event Date 09/28/2015

Event Type  Injury  

Event Description

My cpap developed a hot, dry smell with humidifier, and a high pitched sound that turned into a high pitched squeal.A white powder was discovered inside the machine.I have been using this machine since (b)(6) 2011 and was diagnosed with idiopathic pulmonary fibrosis (b)(6) 2014, and was prescribed oxygen therapy 24/7.It is apparent i had been inhaling this white powder as the machine was slowly disintegrating.Stopped using this machine (b)(6) 2015.

• Brand Name: REMSTAR PRO
• Type of Device: REMSTAR PRO
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 5161659
• MDR Text Key: 28804867
• Report Number: MW5057174
• Device Sequence Number: 1
• Product Code: BZD
• 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: 10/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 450P
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 88