MAUDE Adverse Event Report: RESPIRONICS INC DREAMSTATION AUTO CPAP W/HUMID, BL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BLX500H15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop lung cancer.It is unknown what medical intervention was received by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported that a continuous positive airway pressure (cpap) device's sound abatement foam allegedly became degraded.The patient has indicated medical intervention was required for developing lung cancer.The device was returned to the manufacturer quality product investigation laboratory for further investigation.During the initial visual inspection of the device, minor contaminants were found to be present around inlet filter areas, outlet port and the humidifier latch area.The air inlet filter contained a moderate amount of off-white fibrous material.The device was disassembled for internal visual inspection.The manufacturer found evidence of dust contamination inside the device.The filter housing and inlet area contained minor dark dust or dirt contaminant, and a beige dust or dirt containment.The pollen and ultrafine filters were both almost black in color.Dust or dirt contamination were located on the inside of the blower box, pressure sensor port.An insect was found below the bottom left of the ui panel inside the bottom enclosure channel.Manufacturer also found dark dust or dirt contaminant, and dark fibrous material throughout the airpath.The manufacturer confirms the dust and dirt contamination were from an external source.The sound abatement foam was found to have no evidence of degradation and returned to its original shape after being compressed.Sound abatement foam did have more evidence of dust contamination than the rest of the device.The manufacturer concludes there is no evidence of foam degradation within the device.

• Brand Name: DREAMSTATION AUTO CPAP W/HUMID, BL
• 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: 12210228
• Report Number: 2518422-2021-02437
• Device Sequence Number: 4541757
• Product Code: BZD
• UDI-Device Identifier: 00606959027350
• UDI-Public: 00606959027350
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2022

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: BLX500H15
• Device Catalogue Number: BLX500H15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 05/05/2022
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/13/2021; 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2019
• 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 Sex: Unknown