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

Model Number	CAX400T12
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2018
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 the cpap device's sound abatement foam.There was no report of patient 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 reported incorrect information alleging an issue related to the cpap device's sound abatement foam.The device was returned and particle contamination- black dirt/dust was observed in the blower during device evaluation.There was no report of patient 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: a cpap was returned to the manufacturer for service, due to an allegation of the device was overheating and there was black smoke inside the unit.There was no patient harm or injury reported.During the evaluation at the manufacturer's product investigation laboratory, visual inspection of the received device does show evidence of (black particulate throughout devices.) the installed filters in the dreamstation are contaminated with a black-colored substance and have a sweet smelling odor.The external surface where the filters and the modem are located are also coated with a black-colored substance.The humidifier's water chamber flip lid and dry box seals also are contaminated with the black particulate.The filters are located in the air inlet port of the dreamstation.The location of these dark-colored contaminants in the air inlet filter indicates the source of the contaminants is external to the dreamstation and is not related to a failure of the device.The complaints are due to the devices being used in an environment containing this unknown dark-colored dust contaminant.This contaminant entered the air path of the devices and contaminated the air path.Section e.1 was incorrectly reported in previous report, which is now updated in this follow-up report.

• 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: 13905069
• Report Number: 2518422-2022-11052
• Device Sequence Number: 19950894
• Product Code: BZD
• UDI-Device Identifier: 00606959026575
• UDI-Public: 00606959026575
• 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
• Report Date (Section B): 08/31/2022

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: CAX400T12
• Device Catalogue Number: CAX400T12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2016
• 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
• Patient Sex: Unknown