MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV H/ HT/W, DS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900T11W

Device Problem Degraded (1153)

Patient Problems Headache (1880); Dizziness (2194)

Event Date 07/22/2021

Event Type  malfunction  

Event Description

The manufacturer received a voluntary medwatch (mw-510276) regarding the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient alleges "sinus issues along with headache and dizziness".There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Internal evaluation of the device found evidence of third party or user repair.A third-party blower box with no sound abatement foam was present.The alarm ribbon cable was disconnected from p5.No further evaluation was possible due to third party modification.Pil is also unable to address the symptoms described.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 BIPAP AUTOSV H/ HT/W, DS
• 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: 17994998
• MDR Text Key: 326370376
• Report Number: 2518422-2023-27611
• 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: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX900T11W
• Device Catalogue Number: DSX900T11W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Initial Date Manufacturer Received: 10/22/2022
• Initial Date FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1