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

Model Number	1060657
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2015
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
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient informed alleging a black filter.No allegation of patient harm or injury was reported.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

• Brand Name: BIPAP AVAPS
• 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; 2673970028
• MDR Report Key: 14633490
• Report Number: 2518422-2022-06080
• Device Sequence Number: 3626250
• Product Code: BZD
• UDI-Device Identifier: 00606959043985
• UDI-Public: 00606959043985
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/08/2022

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: 1060657
• Device Catalogue Number: 1060657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2015
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2013
• 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