MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR SE ASSY; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	220P
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient had informed mold in the device.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 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 visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The report states that a white material foreign to the unit was pulled in through back of the device.The complaint noted the fliter in the back of the unit was clogged.No filters were returned with the device.Qa also performed an external and internal visual inspection of the recieved deices and confirmed the engineering evaluation.Qa found evidence of this unknown talc-like contaminant in the air inlet of the remstar auto.The complaints noted the filters were "clogged" with this sybstance, indicatig the filters were not being changed in a timely manner, as noted in the associated user mansuals.Based on these findings and a complete review of the complaint it is concluded that no further investigation into the alleged complaint issue is appropriate at this time.It is also concluded that no futher correspondence or reply to the customer is required t close this complaint and no further investigatory activity will occur involving communications with the customer or otherwise.

• Brand Name: REMSTAR SE ASSY
• 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: 13595563
• Report Number: 2518422-2022-06451
• Device Sequence Number: 1957345
• Product Code: BZD
• UDI-Device Identifier: 00606959038356
• UDI-Public: 00606959038356
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 220P
• Device Catalogue Number: 220P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 09/17/2010
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2013
• 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