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

Model Number DSX400T11C

Device Problems Degraded (1153); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Dyspnea (1816); Headache (1880); Choking (2464); Eye Infections (4466); Swelling/ Edema (4577)

Event Date 10/05/2021

Event Type  Injury  

Event Description

The manufacturer was made aware that a user was allegedly burned on the left side of her face while using her (b)(6) device.User was hospitalized for 2 days with medication and then discharged.The device has not yet been returned for evaluation.The investigation is on-going.After the device has been investigated, a follow up final report will be submitted.

Event Description

The manufacturer was made aware that a user was allegedly burned on the left side of her face while using her dreamstation cpap pro device.User was hospitalized for 2 days with medication and then discharged.The device has not yet been returned for evaluation.The investigation is on-going.After the device has been investigated, a follow up final report will be submitted.

Manufacturer Narrative

The manufacturer previously reported information in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.Additional information was received that the patient is also alleging a swollen face, swollen eye, infection in the left eye, headaches, difficulty breathing/shortness of breath and choking while using the device.Medical intervention was hospitalization and an antibiotic drip.The date of awareness has also been changed to 10/05/2021.The patient also provided an email address.Please see sections b3, e1, g3, and h6 for this updated and corrected information.

Manufacturer Narrative

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 previously received information alleging the patient was placed in the hospital for two days in (b)(6) 2021 because the machine burned on the left side of her face and caused headaches.They put her on double-drip medicine; she's not sure what the name was.Additional information was received that the patient was admitted on (b)(6) 2021, for shortness of breath, face and left eye were swollen, and an was on an antibiotic drip.The patient also alleged infection in the left eye, swollen eyes, and choking while using the device.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h6 updated in this report.

• 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 15206 ; 2673970028
• MDR Report Key: 13286020
• MDR Text Key: 285479251
• Report Number: 2518422-2022-01216
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2023

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: DSX400T11C
• Device Catalogue Number: DSX400T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 10/05/2021; 08/03/2023
• Supplement Dates FDA Received: 09/02/2022; 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER- NO SN KNOWN.
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female