MAUDE Adverse Event Report: RESPIRONICS INC SYSTEM ONE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

The manufacturer was made aware by an end user that a thermal event occurred with a power supply that was being used with a system one continuous positive airway pressure (cpap) device.There was no serial number or product number provided for the device.There was no patient harm or injury associated with the reported event.The user reported that while using the device, he noticed that the power supply's power brick caught fire at which time he quickly unplugged it and blew the flames out.The manufacturer has made repeated attempts to contact the user for additional information and to have the device returned for investigation.No further communication has been received from the user, and no product has been returned for investigation.The power supply is designed in accordance to iec 60601 and applicable parts of iec 60950.Voltage in the cpap/humidifier device is limited to 12 v dc nominal, and current is limited by the device fuse, to minimize the potential for electrical fire.The design of the electronics mechanicals is robust enough to resist damage that would result from typical usage.Based on the information available, the manufacturer is unable to confirm that the device caused or contributed to the reported event.If additional information is received, a supplemental report will be filed.

• Brand Name: SYSTEM ONE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville, pa
• Manufacturer (Section G): RESPIRONICS INC; 1001 murry ridge lane; murrysville, pa
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, pa ; 3349303
• MDR Report Key: 10234127
• MDR Text Key: 197611310
• Report Number: 2518422-2020-01499
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PHILIPS RI POWER SUPPLY