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

Model Number	GBX500H15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Pneumothorax (2012); Irritability (2421); Lethargy (2560); Fibrosis (3167); Nodule (4551)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging that a continuous positive airway pressure (cpap) device's sound abatement foam became degraded.The patient has indicated being diagnosed with bibasal small plate atelectasis, scarring of the lungs and a paramediastinal mass on the lungs.The patient continues to experience tiredness, irritability, lack of energy and shortness of breath.It is unknown what medical intervention was required by the patient.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer was previously 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 that a continuous positive airway pressure (cpap) device's sound abatement foam became degraded.The patient has indicated being diagnosed with bibasal small plate atelectasis, scarring of the lungs and a paramediastinal mass on the lungs.The patient continues to experience tiredness, irritability, lack of energy and shortness of breath.It is unknown what medical intervention was required by the patient.The patient has also reported having bibasal small plate atelectasis, paramediastinal mass on lungs, scarring of lungs, difficultly of breathing/shortness of breath, chest pain, tired, irritable and low energy.The relationship between the device and the reported events is currently unclear.
Additional Manufacturer Narrative
The manufacturer was previously 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 that a continuous positive airway pressure (cpap) device's sound abatement foam became degraded.The patient has indicated being diagnosed with bibasal small plate atelectasis, scarring of the lungs and a paramediastinal mass on the lungs.The patient continues to experience difficultly of breathing/shortness of breath, chest pain, tired, irritable and low energy.No medical intervention was reported.The device was returned to the manufacturer's quality product investigation laboratory for investigation.Investigation observed an unknown dust contaminant inside the blower box at the air inlet.An unknown contaminant was observed inside the iso port of the rear panel, on the top enclosure, and front panel exteriors.An unknown dust contaminant was observed on the interior of the front panel, rear panel, bottom enclosure, blower, blower seal, and blower box and dust in the airpath was confirmed.Evidence of liquid ingress with a dust contaminant consistent with mineral deposits was observed to the blower and blower box.A keratin-like substance was observed on the blower box outlet.Evidence of sound abatement foam degradation/breakdown was not observed.Investigation confirmed no presence of degraded sound abatement foam using a fitt and the associated procedure.Investigation can confirm that there was no evidence of sound abatement foam degradation/breakdown observed in the base unit.

• Brand Name: DREAMSTATION AUTO CPAP
• Common Device Name: 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: 12599126
• Report Number: 2518422-2021-04669
• Device Sequence Number: 4023717
• Product Code: BZD
• UDI-Device Identifier: 00606959042292
• UDI-Public: 00606959042292
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: GBX500H15
• Device Catalogue Number: GBX500H15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 08/04/2023; 10/12/2023
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 08/18/2023; 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Female