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

Model Number DSX400H11C

Device Problem Material Disintegration (1177)

Patient Problems Inflammation (1932); Unspecified Respiratory Problem (4464); Renal Impairment (4499); Unspecified Kidney or Urinary Problem (4503); Skin Inflammation/ Irritation (4545)

Event Date 08/28/2023

Event Type  Injury  

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 is experiencing eye irritation, nose irritation, skin irritation, respiratory tract irritation, inflammatory response, kidney disease/toxicity, lung disease, kidney disease and respiratory illness.Medical intervention was not specified.At this time, no further investigation can be performed.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: DREAMSTATION CPAP PRO
• 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: 17775042
• MDR Text Key: 323749648
• Report Number: 2518422-2023-23724
• 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: Other,Company Representative
• 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: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DSX400H11C
• Device Catalogue Number: DSX400H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2020
• 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
• Patient Outcome(s): Life Threatening