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

Model Number	FR1165X
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2017
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 bipap device's sound abatement foam.The complaint includes blower is noisy, water degradation, blower assembly, blower cap, blower housing, right panel assembly and sound abatement foam needs to be replaced.There was no report of serious or permanent 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 previously reported that hospitalization - initial or prolonged, required intervention to prevent permanent impairment/damage, disability or permanent damage, congenital anomaly/ birth defect occured in outcomes attributed to adverse event.After review, it was determined that all these were incorrectly selected in outcomes attributed to adverse event.Nothing such has occured to the patient.

• Brand Name: BIPAP AVAPS C SERIES
• 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: 13790556
• Report Number: 2518422-2022-10498
• Device Sequence Number: 3905756
• Product Code: BZD
• UDI-Device Identifier: 00606959039087
• UDI-Public: 00606959039087
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: FR1165X
• Device Catalogue Number: FR1165X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Congenital Anomaly; Disability
• Patient Sex: Unknown