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

Model Number	CAX400T12C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged breathing issue and fill pressure on his chest.There was no report of serious or permanent harm or injury.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 marked h10 incorrectly.This mdr was not submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints discovered as part of a retrospective remediation review.
Additional Manufacturer Narrative
The manufacturer previously reported incorrect information in section b5 as receiving information alleging an issue related to a cpap device's sound abatement foam.The patient alleged breathing issue and fill pressure on his chest.There was no report of serious or permanent harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058 section b5 should have been 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 user allegesbreathing issue and fill pressure on his chest.There was no serious patient harm or injury reported.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 initially received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged breathing issue and fill pressure on chest.There was no patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection was completed by the manufacturer.The manufacturer found evidence of dark unknown dust contaminant on the front panel and rear panel.A dust contaminant and an unknown particle contaminant were present on the bottom enclosure.A hair-like particle was observed on the blower box.An unknown dust contaminant was observed on the blower, blower seal, and blower box.Evidence of liquid ingress was observed to the blower and blower box.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The manufacturer concludes that the dark unknown dust contaminant on the front panel and rear panel, dust contaminant and an unknown particle contaminant were present on the bottom enclosure, hair-like particle was observed on the blower box, unknown dust contaminant was observed on the blower, blower seal, and blower box, evidence of liquid ingress was observed to the blower and blower box inconsistent with the sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation.Section h4 had incorrect data which is corrected in this report.Section d8, d9, g3, h6 has been updated/corrected.

• 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: 13952149
• Report Number: 2518422-2022-11151
• Device Sequence Number: 4611811
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 08/04/2021; 04/21/2023
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 07/12/2022; 09/07/2022; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2018
• 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
• Patient Sex: Unknown