MAUDE Adverse Event Report: RESPIRONICS INC REMSTAR AUTOA-FLEX W/HUM,SYSONE60SRS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AU561HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap).Device's sound abatement foam became degraded and caused the patient to have sinus infection.The patient did receive medical intervention in the form of prescription for antibiotics.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

• Brand Name: REMSTAR AUTOA-FLEX W/HUM,SYSONE60SRS
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• Manufacturer (Section G): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13121440
• Report Number: 2518422-2021-08582
• Device Sequence Number: 14582286
• Product Code: BZD
• UDI-Device Identifier: 00606959005495
• UDI-Public: 00606959005495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: AU561HS
• Device Catalogue Number: AU561HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2014
• 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
• Patient Age: 55 YR
• Patient Sex: Female