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

Model Number	DSX600T11C
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware that a user alleges while using a bi-level continuous positive airway pressure (bipap) device, the user developed water condensation in his tubing which he aspirated into his lungs.The user went to the hospital and was admitted on (b)(6) 2020 and was discharged home on (b)(6) 2020.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 bipap device and associated heated humidifier and accessories for investigation.There were no operational issues noted, and the devices passed all testing.The manufacturer was unable to reproduce the condition of excessive condensation (rainout) in the patient circuit.Patient data shows that the heated tubing was not enabled for 15 days from set up.When the tubing was enabled on 8/21/2020, it was only set to #1 of 5 incremental settings.Setting the heated tubing setting at a higher number would have been significantly reduced the rainout.Also noted, oxygen was bled into the mask at 4 lpm using a bubble humidifier which added additional humidity.A room humidifier was also in use at that time which contributed to the rainout.The use of heated tubing when properly configured, is intended to reduce the occurrence of rainout.The occurrence of rainout is typically a result of the humidification not being properly configured for the environmental conditions in which the humidifier is being used.The dreamstation humidifier user manual advises users to position the cpap with humidifier lower than the sleeping position and on a firm, flat, level surface.There was no permanent harm or injury reported.Based on the available information, no further action is necessary.

• Brand Name: DREAMSTATION BIPAP PRO
• Common Device Name: VENTILATORY, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa
• MDR Report Key: 10484116
• Report Number: 2518422-2020-02047
• Device Sequence Number: 3974712
• Product Code: BZD
• UDI-Device Identifier: 00606959025677
• UDI-Public: 00606959025677
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: DSX600T11C
• Device Catalogue Number: DSX600T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEATED HUMIDIFIER (B)(4); OXYGEN CONCENTRATOR- 4 LPM BLED INTO MASK; HEATED HUMIDIFIER (B)(4); OXYGEN CONCENTRATOR- 4 LPM BLED INTO MASK
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR