MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; CPAP

Model Number	DV53D
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving a cpap by an end-user, who reported that the power cord for his unit "got hot, smoking and on fire", and he suffered burns to his fingers.The end-user noted the cpap was plugged into a "power strip" with numerous other devices.He stated the event occurred when he partially pulled the cpap plug from the strip and then re-inserted it.The end-user did not seek medical treatment for his injury.Devilbiss requested the unit be returned for investigation and will file an update if additional information becomes available.

• Brand Name: DEVILBISS
• Common Device Name: CPAP
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: roberto munoz ; 100 devilbiss drive; somerset, PA 15501
• MDR Report Key: 17462372
• Report Number: 2515872-2023-00077
• Device Sequence Number: 7106099
• Product Code: BZD
• UDI-Device Identifier: 00885304001874
• UDI-Public: 00885304001874
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DV53D
• Device Catalogue Number: DV53D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male