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

Model Number	AUX400T15C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	07/21/2021
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 the patient to develop a nasal polyp and an inverted papilloma.The patient required surgical removal of the inverted papilloma and nasal polyp in response to the reported event.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 (b)(4).
Additional Manufacturer Narrative
The manufacturer previously repored an issue related to a cpap device's sound abatement foam.The patient alleged to develop a nasal polyp and an inverted papilloma.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.An external visual inspected was completed by the manufacturer.The manufacturer found evidence of moderate dust contamination on the pollen filter and a spot left of the therapy button of unknown origin.Power was applied to the device and the manufacturer verified that the device provides therapy.The manufacturer reviewed the device's event logs and found no errors logged.The device was visually inspected internally and found evidence of dust and dirt contaminates to the blower box, blower and blower impeller.The humidifier was inspected and found carbonaceous deposits on the water tank and discolored spots on the flip lid seal, as well as dust and dirt.A microscopic review of the contaminants was completed by the manufacturer.The comtaminates were confirmed to be small insects 2-3mm long.There was no report of sound abatement foam degradation.The manufacturer confirms the contamination is that of the operating environment and insect contamination.

• Brand Name: DREAMSTATION CPAP PRO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12230182
• Report Number: 2518422-2021-02478
• Device Sequence Number: 17360550
• Product Code: BZD
• UDI-Device Identifier: 00606959034792
• UDI-Public: 00606959034792
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2022

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: AUX400T15C
• Device Catalogue Number: AUX400T15C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 12/17/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/13/2021; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HUMIDIFIER H171682854C0EMODEM CT90302703440
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female