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

Model Number DSX700T11C

Device Problem Degraded (1153)

Patient Problems Laceration(s) (1946); Ulcer (2274); Unspecified Respiratory Problem (4464); Unspecified Tissue Injury (4559)

Event Date 07/31/2020

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 in a previous ra 308504928.The manufacturer received information alleging the patient experienced issues with her nose while using the device.The patient stated her nose was running and swollen and developed ulcers/lacerations inside her nose.Patients states she was prescribed ointment for the prevention of infection.The patient states when using the device, the pressure went higher and caused harm in her nose.The settings on the device were checked by the dme and the settings were correct.The patient confirmed using nasal pillows.The device was returned to the manufacturer quality product investigation laboratory for further investigation.The device was visually inspected.The external investigation found no evidence of damage or contamination.The device's error log was reviewed, and the manufacturer confirmed no errors were logged.An internal investigation was performed on the device.The manufacturer confirmed the device had no evidence of foam degradation.No other information has been received however if additional information is received a supplemental/follow up will be sent.

Manufacturer Narrative

The manufacturer previously reported type of reportable event as injury in section h1.After review, it was determined type of reportable event should have been serious injury.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 17011017
• MDR Text Key: 316028667
• Report Number: 2518422-2023-12278
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DSX700T11C
• Device Catalogue Number: DSX700T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2019
• 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): Other