MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION CPAP PRO W/HUM/HT/CELL, CAN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CAX400T12C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient discovered nodules forming in one lung.The patient required medical intervention in the form of a doctor's assessment.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 an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam allegedly became degraded and the patient discovered nodules forming in one lung.The patient required medical intervention in the form of a doctor's assessment.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.An external inspection of the device was completed by the manufacturer.The manufacturer found small amount of white colored talc- like contaminate in the fresh air intake port.The source of contaminates found in the fresh air intake port is consistent with being from an external source.The manufacturer found the humidifier flip lid to be broken and have dark colored contaminates un the lid latch, in the dry box's release tab flip lid seal and dirt and dust in the cradle area.An internal inspection of the device was completed by the manufacturer.The manufacturer found evidence of contamination and physical damage.The manufacturer found dark colored contamination in the bottom enclosure there was no evidence of contamination of the blower motor or blower box.There was no evidence of sound abatement foam degradation.The humidifier had evidence of dark contamination on the rear panel and flip lid tabs were broken off.The dark colored contamination on the inside bottom of the dreamstation and the rear portion of the humidifier is consistent with improper cleaning methods and physical damage consistent with the device being dropped.The device's downloaded event log was reviewed by the manufacturer and found no errors logged.The device was powered on and provided flow.The manufacturer concludes there was no evidence of sound abatement foam degradation.The dark contaminates observed were consistent with improper cleaning and the physical damage was caused by the device being dropped.
Additional Manufacturer Narrative
Additional information was received on nov 01, 2024, and section h11 should be reported as: 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 the manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient discovered nodules forming in one lung.The patient required medical intervention in the form of a doctor's assessment.There was no report of serious patient harm or injury.

• Brand Name: DREAMSTATION CPAP PRO W/HUM/HT/CELL, CAN
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer Contact: rosko melissa ; 6501, living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12278718
• Report Number: 2518422-2021-02638
• Device Sequence Number: 19826163
• Product Code: BZD
• UDI-Device Identifier: 00606959034518
• UDI-Public: 00606959034518
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 11/13/2024

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: CAX400T12C
• Device Catalogue Number: CAX400T12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 10/29/2021; 11/01/2024
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/10/2021; 07/27/2022; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2017
• 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 Sex: Female