MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION CPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BLX400S15
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of an allegation by a user of a continuous positive airway pressure machine (cpap) device's tubing becoming disconnected from his mask during sleep and blowing cold air on his right armpit causing a third degree cold burn.No heated tubing or humidifier was in use at the time of the event.The user reportedly followed up with a dermatologist to treat his burn.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer received the cpap device for investigation.There were no operational issues noted and the device functioned as designed.Temperatures measured during the investigation were within specification.The data logged by the device indicated there were no unintentional circuit disconnects during the dates of the alleged event.Based on the information available, the manufacturer is unable to confirm the allegation of the end user receiving a cold air burn to his armpit due to a tubing disconnect during therapy.There was no serious patient harm or injury.The manufacturer concludes that no further action is necessary.

• Brand Name: DREAMSTATION CPAP PRO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 8519402
• Report Number: 2518422-2019-00830
• Device Sequence Number: 1501444
• Product Code: BZD
• UDI-Device Identifier: 00606959027329
• UDI-Public: 00606959027329
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: BLX400S15
• Device Catalogue Number: BLX400S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other