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

Model Number	JPXH
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
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 related to the device's sound abate foam.This action was reported to fda per 21 cf1 part 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be 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.The manufacturer previously information alleging having black trash has gotten into the mainbody issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for further evaluation.The manufacturer observed the evidence of visual inspection revealed that black point-like dirt, whose size was about two millimeters in a diameter, had clung to a gap between the main body and clear resin part on the inner part of the dreamstation water tank.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Section h6 has been updated in this report.

• Brand Name: DREAMSTATION HUMIDIFIER
• 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: 12215769
• Report Number: 2518422-2021-02382
• Device Sequence Number: 4302143
• Product Code: BZD
• UDI-Device Identifier: 00606959033368
• UDI-Public: 00606959033368
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2023

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: JPXH
• Device Catalogue Number: JPXH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 03/31/2022
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 09/02/2021; 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• 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