MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PLUS C-FLEX CPAP SYSTEM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	261P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2015
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
A ventilator was returned for service.There was no harm or injury reported.During the evaluation at the manufacturer's service center, the sound abatement foam was replaced for repair.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported death, life-threatening, which was marked incorrectly as this is product problem only as mentioned in previous report.Incorrectly marked 30 days and initial including 15 days, which should marked as 30 days and initial only in this follow up report.Incorrectly marked in previous report, which is correctly marked as consumer and foreign in this follow up report.
Additional Manufacturer Narrative
The device was retuned to the manufacturer and tobacco contamination observed during device evaluation.Device available for evaluation, initial reporter name and address, pma/510k, device evaluated by mfr were updated/corrected in this report.

• Brand Name: REMSTAR PLUS C-FLEX CPAP SYSTEM
• 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: 14132232
• Report Number: 2518422-2022-11354
• Device Sequence Number: 16717137
• Product Code: BZD
• UDI-Device Identifier: 00606959028654
• UDI-Public: 00606959028654
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2022

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: 261P
• Device Catalogue Number: 261P
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 10/07/2015
• Supplement Date Received by Manufacturer: 10/07/2015; 08/23/2022
• Initial Report FDA Received Date: 04/17/2022
• Supplement Report FDA Received Date: 04/18/2022; 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2013
• 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