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

Model Number	DEX400S13
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
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 lymph node cancer in the nose and undergoing clinical treatment and chemotherapy as a result.It has been reported that the patient is currently cured.This issue was reported to the fda per 21 cfr 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 being diagnosed with lymph node cancer in the nose and undergoing clinical treatment and chemotherapy as a result.It has been reported that the patient is currently cured.The device was returned to the manufacturer quality product investigation laboratory for further investigation.During the initial visual investigation of the exterior of the device, found evidence of minor contaminants present around the inlet filters area, outlet port, and humidifier latch area.External inspection of the ds1 base unit found minor physical damage.The inlet housing and inlet area are contaminated with dust and dirt.The outlet port was found to have evidence of dust and dirt contamination.The area around the outlet port and the humidifier latching ledge contained dark dust or dirt contamination.Component p4 had evidence of rust discoloration.Internal investigation was completed by the manufacturer.The manufacturer found the device to have contamination.There was minor dust or dirt contamination inside the pressure sensor port the blower box to blower seal was deformed and not fully seated, which may have caused turbulence in the blower box area.The manufacturer found dark dust or dirt contamination throughout the device and device's airpath.The sound abatement foam had no evidence of degradation.The manufacturer concludes there is no evidence of sound abatement foam degradation within the device.The presence of contaminates were from an external source.

• Brand Name: DREAMSTATION CPAP PRO
• 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: 12602236
• Report Number: 2518422-2021-04684
• Device Sequence Number: 19880177
• Product Code: BZD
• UDI-Device Identifier: 00606959024083
• UDI-Public: 00606959024083
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: DEX400S13
• Device Catalogue Number: DEX400S13
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 10/09/2021
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2017
• 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: Required Intervention; Other
• Patient Sex: Unknown