MAUDE Adverse Event Report: RESPIRONICS INC DREAMSTATION EXPERT W/HUM, CAN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CAX501H12
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Chest Pain (1776); Dizziness (2194); Respiratory Tract Infection (2420); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
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 incorrect, the correct b5 should be- 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 voluntary medwatch (mw5102229 and mw5102223).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged seeing black particles, chest pain, sinus pressure and dizziness.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 were completed by the manufacturer and found evidence of unknown dust contaminant on the bottom enclosure, unknown dust contaminant on the blower box, liquid ingress on the blower and blower box, keratin-like substance on the blower box outlet.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 liquid ingress on the blower and blower box, keratin-like substance on the blower box outlet and unknown dust contaminant on the bottom enclosure, unknown dust contaminant on the blower box were inconsistent with sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation.In this report, section a1, d9, g3, h6 have been updated/corrected.

• Brand Name: DREAMSTATION EXPERT W/HUM, CAN
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• 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: 12360143
• Report Number: 2518422-2021-03408
• Device Sequence Number: 19767214
• Product Code: BZD
• UDI-Device Identifier: 00606959053168
• UDI-Public: 00606959053168
• 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
• Report Date (Section B): 05/18/2023

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: CAX501H12
• Device Catalogue Number: CAX501H12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 04/17/2023
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/15/2021; 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2020
• 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