MAUDE Adverse Event Report: PHILIPS 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 Code	Asthma (1726)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop asthma.There is no report of the medical intervention that the patient has received at this time.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.The end user indicated ozone or other unapproved cleaning and disinfection method was used.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 reported a continuous positive airway pressure (cpap) device's sound abatement foam allegedly became degraded and caused a patient to develop asthma.There is no report of the medical intervention that the patient has received at this time.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.An external inspection of the device was completed by the manufacturer.The manufacturer found the gross particle filter clogged with dust and dirt.The ultra fine filter was also heavily contaminated with dust.An internal inspection of the device was completed by the manufacturer.The manufacturer found evidence of minor dust contamination throughout the device's blower box and blower.The manufacturer also found evidence of water ingress to the blower box and blower.The manufacturer tested the device for overheating using the returned filters.The manufacturer confirmed the device's temperatures were below the maximum temperature standards.The device was tested for particulate by placing a bacterial filter at the patient port during testing.There was no evidence of sound abatement foam degradation.The manufacturer applied power to the device and confirmed the device provided airflow.The device's downloaded event log was reviewed and found one error code for a reboot error was logged.The manufacturer concludes there was no evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION EXPERT W/HUM, CAN
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12318215
• Report Number: 2518422-2021-03085
• Device Sequence Number: 19960299
• 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): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/06/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 10/29/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/13/2021; 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female