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

Lot Number 2021062301231896

Device Problems Break (1069); Nonstandard Device (1420); Gas/Air Leak (2946)

Patient Problems Sleep Dysfunction (2517); Unspecified Respiratory Problem (4464)

Event Date 07/29/2021

Event Type  Injury  

Event Description

Complainant reports his cpap is emitting gases caused by foam breaking down.He is aware of the philip recall for his cpap, and he has initiated his complaint through their process as stated in their recall.Complainant states he is not receiving any guidance from the company regarding the next step to retrieve and replace his cpap.Notification date: 07/30/2021, health professional attended, hospitalization not required.Difficulty breathing/respiratory; sleep problems, nervous.Provider name: dr.(b)(6), defective: emitting gases caused by foam.On (b)(6) 2021 dal-do ccc: complainant was contacted and provided the fda website landing page for this recall: as the medical device manufacturer, philips respironics has a responsibility not only to ensure the manufacture of safe and effective devices, but also to establish an appropriate mitigation strategy to reduce public harm in the event of device failure or defect.The fda is reviewing the information philips respironics has provided regarding replacement devices while continuing to work with philips respironics on their corrective actions for existing devices.As the fda reviews this info, the fda will determine whether the proposed replacement devices pose any add'l risk to people who use these devices.Complaint: (b)(4).

• Brand Name: CPAP DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 12306812
• MDR Text Key: 266371889
• Report Number: MW5103131
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/10/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 2021062301231896
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1