MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PROCFLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AU461TS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Fatigue (1849); Respiratory Tract Infection (2420); Sleep Dysfunction (2517); Cough (4457)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
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 received information alleging coughing, bronchitis, upper respiratory infections, post nasal drip, fatigue and sleep disturbances while using the device.Patient also alleged black particles in the device.Medical intervention was prophylactic antibiotics.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Additional information was received on 12 dec, 2024 and section h11 should be reported as: 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 coughing, bronchitis, upper respiratory infections, post nasal drip, fatigue and sleep disturbances while using the device.Patient also alleged black particles in the device.Medical intervention was prophylactic antibiotics.There was no report of serious patient harm or injury.Section b1 was corrected for product problem.(both adverse event and product problem was checked in the previous mdr.) section b2 was corrected to blank.(previously, it was other serious or important medical events.) section h1 was changed from serious injury to malfunction.Section h6 health effects: clinical codes and health effects - impact code was corrected.

• Brand Name: REMSTAR PROCFLEX+
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge ln; murrysville; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer Contact: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 15258401
• Report Number: 2518422-2022-73893
• Device Sequence Number: 5745991
• Product Code: BZD
• UDI-Device Identifier: 00606959005457
• UDI-Public: 00606959005457
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: AU461TS
• Device Catalogue Number: AU461TS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• 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 Age: 50 YR
• Patient Sex: Female