MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PROCFLEX+W/HTHUMSYSONE,60SRS,AUS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AU461TS
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted regarding a remstar procflex+w/hthumsysone,60srs, aus device.Per the repair work order (rwo) and the photos provided, the device has black particles and gunk in the inline filter; there are no allegations of particles in the mask or hosing.There are no allegations of serious injury or patient harm.No clinical information or medical intervention has been specified.No further investigation can be carried out at this time.If additional information is received after inspection and analysis of the device, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported information regarding a remstar procflex+w/hthumsysone,60srs, aus device.Per the repair work order (rwo) and the photos provided, the device has black particles and gunk in the inline filter; there are no allegations of particles in the mask or hosing.There are no allegations of serious injury or patient harm.No clinical information or medical intervention has been specified.No further investigation can be carried out at this time.A follow-up report will be filed if additional information is received after the device is inspected and analyzed.The previous report was initially filed as an initial-final report.Upon correcting it, it is now filed it as an initial report.

• Brand Name: REMSTAR PROCFLEX+W/HTHUMSYSONE,60SRS,AUS
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19813540
• Report Number: 2518422-2024-46655
• Device Sequence Number: 8665350
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: AU461TS
• Device Catalogue Number: AU461TS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male