MAUDE Adverse Event Report: RESPIRONICS, INC. A40 SILVER SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1116153
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2018
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 bipap device's sound abatement foam.The complaint includes bottom enclosure was broken, inlet foam was damaged.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 required intervention to prevent permanent impairment/damage, disability or permanent damage, congenital anomaly/ birth defect occured.After review, it was determined that all these were incorrectly selected.Nothing such has occured to the patient.

• Brand Name: A40 SILVER 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: 13862327
• Report Number: 2518422-2022-11504
• Device Sequence Number: 14619141
• Product Code: BZD
• UDI-Device Identifier: 00606959042834
• UDI-Public: 00606959042834
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 1116153
• Device Catalogue Number: 1116153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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: Congenital Anomaly; Disability; Required Intervention
• Patient Sex: Unknown