MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1130T11

Device Problem Degraded (1153)

Patient Problems Liver Damage/Dysfunction (1954); Renal Failure (2041); Cancer (3262); Unspecified Kidney or Urinary Problem (4503)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : the device has not yet been returned to the 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 end stage renal disease on hemodialysis, cryptogenic cirrhosis, acute kidney injury and hepatocellular carcinoma.No other clinical information or medical interventions were reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION BIPAP AVAPS30
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19084494
• MDR Text Key: 339875400
• Report Number: 2518422-2024-17946
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1130T11
• Device Catalogue Number: DSX1130T11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2018
• 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
• Patient Outcome(s): Other