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

Model Number	GBX500S15
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
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.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer was previously 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 information alleging black bits observed.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for further evaluation.The device was visually inspected and found evidence of mineral deposits consistent with water ingress on the blower motor and inside the blower box.The manufacturer found evidence of a dust like contamination to th eair input of the blower box.Black contamination consistent with keratin was found at the air outlet of the blower box and blower motor seal.There was no evidence of sound abatement foam degradation.The device's downloaded logs were reviewed by the manufacturer and found no errors logged.The manufacturer concludes there was evidence of contamination consistent with water ingress, dust like contamination and keratin.There was no evidence of sound abatement foam degradation found within the device.
Additional Manufacturer Narrative
Additional information was received and section h10 should be corrected 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.The manufacturer previously received information alleging an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged the black bits observed.There was no report of patient harm or injury.During the subsegent testing of the device, there was evidence of sound abatement foam degardation.The manufacturer used a fitt (foam integrity test tool) and was able to confirm the presence of degraded sound abatement foam.The manufacturer concludes there was evidence of sound abatement foam degradation.Section h6 type of investigation, investigation findings and investigation conclusions has been corrected.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12573398
• Report Number: 2518422-2021-04673
• Device Sequence Number: 3585834
• Product Code: BZD
• UDI-Device Identifier: 00606959042285
• UDI-Public: 00606959042285
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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: GBX500S15
• Device Catalogue Number: GBX500S15
• 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: 09/24/2021
• Supplement Date Received by Manufacturer: 10/26/2022; 07/13/2023
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 12/09/2022; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2016
• 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