MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900T11C

Device Problem Degraded (1153)

Patient Problem Dyspnea (1816)

Event Date 09/16/2021

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging the patient has difficulty breathing and shortness of breath.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.The device was returned to a third-party service center regarding the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the device evaluation, the device was visually inspected and scrapped.There was no evidence of foam degradation, foam particles visible, and the third-party service center could not confirm the user's complaint of hose blockage.

Manufacturer Narrative

H3 other text : the device has been sent to a third-party service center in order to process.

• Brand Name: DREAMSTATION BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 17733360
• MDR Text Key: 323404262
• Report Number: 2518422-2023-22544
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: 505
• Remedial Action: Repair
• Type of Report: Initial

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: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1