MAUDE Adverse Event Report: RESPORINOC INC REMSTAR AUTOA-FLEX W/ HUM, SYSONE 60SRS, AUS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AU561HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Pneumonia (2011); Cancer (3262)
Date of Event	08/05/2021
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 the patient developed a mass in his lungs.The details of the medical intervention that the patient required are currently unknown.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.Corrected data: e1 initial reporter (contact/phone number): previously reported as (b)(6).G4 pma/510(k) number: previously reported as k113068 ; updated to k091319.
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging a cpap device's sound abatement foam became degraded and the patient developed a mass in his lungs.The details of the patient's required medical intervention are unknown.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 updated in this report.
Additional Manufacturer Narrative
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient developed a mass in his lungs.Patient suffered from pneumonia, has copd & asthma.The details of the medical intervention that the patient required are currently unknown.In previous mdr health clinical codes are missing in this repot corrected and updated.

• Brand Name: REMSTAR AUTOA-FLEX W/ HUM, SYSONE 60SRS, AUS
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPORINOC INC; 101 murry ridge lane; murrysville, pa PA 15668
• Manufacturer (Section G): RESPORINICS, INC; 1001 murry ridge lane; murrysville,pa PA 15668
• Manufacturer Contact: rosko melissa ; 6501 living place; pittisburgh,pa, PA 15206 ; 7243512041
• MDR Report Key: 12310916
• Report Number: 2518422-2021-02875
• Device Sequence Number: 20402227
• Product Code: BZD
• UDI-Device Identifier: 00606959005495
• UDI-Public: 00606959005495
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/23/2024

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
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/02/2022; Not provided
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/14/2021; 08/29/2023; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2012
• 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: Other
• Patient Sex: Male