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

Model Number	CAX400T12
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
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.There was no allegation of 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 additional manufacturer narrative 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 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.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.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 previously received information alleging an issue related to a cpap device's sound abatement foam.There was no allegation of harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.In the initial report, section a1, a2, a3 were not marked, and section e1 was incorrect.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of device, and humidifier were completed by the manufacturer and found evidence of dust/dirt contamination at the air inlet, iso port, on the front and back panel, motor casing/impellers, and blower box was inconsistent with degraded sound abatement foam, contamination throughout the airpath.Mineral spots consistent with water ingress on the blower box and motor casing, slight black contamination at the blower seal of the blower box appears consistent with the keratin contamination, dust/dirt contamination within the humidifier unit, on the iso port, within the dry box and dry box assembly, on the dry box seal, and on the edge of the heater plate, mineral spots within the humidifier unit on the dry box seal and heater plate.The manufacturer found no evidence of sound abatement foam degradation.Pil confirmed that the heater plate and the heater tube heats using a known good power supply.The device's downloaded event log was reviewed by the manufacturer and found 2 instances of e-130, e-200 and e-4, 4 instances of e-53 and 2 instances of stop error e-200.The manufacturer concludes the contaminates found were consistent with dust/dirt contamination within the humidifier unit, on the iso port, within the dry box and dry box assembly, on the dry box seal, and on the edge of the heater plate, mineral spots within the humidifier unit on the dry box seal and heater plate, contamination throughout the airpath.Mineral spots with water ingress on the blower box and motor casing, slight black contamination at the blower seal of the blower box appears with the keratin contamination.The manufacturer confirmed there was no evidence of sound abatement foam degradation.In this report, section a1, a2, a3, d9, d10, e1, g3, h6 have 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: 13952162
• Report Number: 2518422-2022-11172
• Device Sequence Number: 11915246
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/30/2023

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: CAX400T12
• Device Catalogue Number: CAX400T12
• 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: 09/23/2021
• Supplement Date Received by Manufacturer: 09/23/2021; 09/23/2021; 06/22/2023
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 07/12/2022; 09/07/2022; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2019
• 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 EUXHCP (B)(6)
• Patient Age: 83 YR
• Patient Sex: Female