MAUDE Adverse Event Report: RESPIRONICS, INC. ESSENCE RENTAL WITH SSD 230V50HZ; COMPRESSOR/NEBULIZER

Model Number	R1112261
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2022
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging an issue related to a essence rental with ssd 230 device.The patient has allegedly passed away.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: ESSENCE RENTAL WITH SSD 230V50HZ
• Common Device Name: COMPRESSOR/NEBULIZER
• 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: 20311002
• Report Number: 2518422-2024-59789
• Device Sequence Number: 7791778
• Product Code: BTI
• UDI-Device Identifier: 00383730001951
• UDI-Public: (01)00383730001951
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042655
• 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
• Report Date (Section B): 09/26/2024

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: R1112261
• Device Catalogue Number: R1112261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2020
• 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