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

Model Number	CAX400H12C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Headache (1880); Inflammation (1932); Dizziness (2194); Sore Throat (2396); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
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.There was no report of patient harm or injury.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 received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm or injury.In the initial report, section b5 was not updated, the correct b5 should be- the patient has alleged headaches, sore throat, dizziness, lightheaded, shortness of breath, nasal soreness, and chest pain.There was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of device was completed by the manufacturer and found evidence of dark dust contaminant on the top enclosure, front panel, rear enclosure, and bottom enclosure, unknown dust contaminant on the blower, blower seal, and blower box, keratin-like substance on the blower box outlet, liquid ingress on 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 device was applied power and the device operated properly.The manufacturer concludes the contaminates found were consistent with dark dust contaminant on the top enclosure, front panel, rear enclosure, and bottom enclosure, keratin-like substance on the blower box outlet, liquid ingress on the blower and blower box and an unknown dust contaminant on the blower was inconsistent with the sound abatement foam the manufacturer confirmed there was no evidence of sound abatement foam degradation.Section a1, d9, g3, h6 have been updated/corrected.
Additional Manufacturer Narrative
In the previous report, section b5 was not updated, the correct b5 should be- the patient has alleged headaches, sore throat, dizziness, lightheaded, shortness of breath, nasal soreness, respiratory issues, inflammation and chest pain.There was no report of serious or permanent patient harm or injury.In this report, section 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 15568
• Manufacturer (Section G): PHILIPS RESPIRONICS; 6501 living place; pittsburgh PA 15206
• Manufacturer Contact: rodney mell ; 1001 murry ridge lane; murrysville, PA 15668 ; 7249003460
• MDR Report Key: 12159581
• Report Number: 2518422-2021-02150
• Device Sequence Number: 14417384
• Product Code: BZD
• UDI-Device Identifier: 00606959034501
• UDI-Public: 00606959034501
• 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): 03/23/2023

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: CAX400H12C
• Device Catalogue Number: CAX400H12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 03/20/2023; 03/24/2023
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 09/09/2021; 03/22/2023; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2017
• 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
• Patient Sex: Unknown