MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	RGBX500S15
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information regarding a dreamstation auto cpap.The manufacturer was advised that the patient sadly passed away.There is no allegation that the device contributed to the patient's death.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The complaint notification reported the dreamstation cellular modem as the suspected device.Material number: r100621c.Serial number: (b)(6).Udi number: (b)(4).H3 other text : device not returned to the manufacturer.
Additional Manufacturer Narrative
The manufacturer was previously contacted regarding a dreamstation auto cpap.The manufacturer was advised that the patient sadly passed away.There is no allegation that the device contributed to the patient's death.In box d: product brand name, model number (rfb), model number, catalog item identifier (rfb), catalog item identifier, serial number (rfb), serial number, product udi (rfb), device identifier (gtin) are updated in this follow-up.In box h: manufacture date (rfb) and manufacture date are updated in this follow-up.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 18958336
• Report Number: 2518422-2024-14825
• Device Sequence Number: 19968665
• Product Code: BZD
• UDI-Device Identifier: 00606959023222
• UDI-Public: (01)00606959023222
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RGBX500S15
• Device Catalogue Number: RGBX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2019
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown