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

Model Number DSX200H11

Device Problem Degraded (1153)

Patient Problems Headache (1880); Sleep Dysfunction (2517); Unspecified Heart Problem (4454)

Event Date 08/11/2011

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

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 that after open heart surgery the patient was experiencing a lot of headaches and problems sleeping.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.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
• 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: 18223030
• MDR Text Key: 329192134
• Report Number: 2518422-2023-32183
• 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
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX200H11
• Device Catalogue Number: DSX200H11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: K131982
• Patient Sequence Number: 1
• Patient Outcome(s): Other