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

Model Number DSX400T11C

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a dreamstation cpap pro device's sound abatement foam.The patient has alleged house is on fire.There was no report of serious or permanent harm or injury.The device was evaluated, and evaluation result stated that the complaint was not confirmed and there has water ingress that cause no power in device.The device was scrapped due to device not required for internal stocking.Manufacturer did not confirm any foam particles.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

In previous report the manufacturer received information alleging an issue related to a dreamstation cpap pro device's sound abatement foam.The patient has alleged house is on fire.There was no report of serious or permanent harm or injury.The device was evaluated, and evaluation result stated that the complaint was not confirmed and there has water ingress that cause no power in device.The device was scrapped due to device not required for internal stocking.Manufacturer did not confirm any foam particles.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Correction to the part b5 section, the manufacturer received information alleging an issue related to a dreamstation cpap pro device's, the patient has alleged house is on fire.There was no report of serious or permanent harm or injury.The device was evaluated, and evaluation result stated that the complaint was not confirmed and there has water ingress that cause no power in device.The device was scrapped due to device not required for internal stocking.Manufacturer did not confirm any foam particles.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: DREAMSTATION CPAP PRO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18010624
• MDR Text Key: 326600273
• Report Number: 2518422-2023-27813
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX400T11C
• Device Catalogue Number: DSX400T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1