MAUDE Adverse Event Report: RESPIRONICS, INC. ESSENCE WITH SSD & SSR; COMPRESSOR/NEBULIZER

Model Number	1100312
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a essence with ssd & ssr device's sound abatement foam.The patient has alleged cord caught on fire and burning smell was observed within the device.There was no report of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device evaluated by third party service center.
Additional Manufacturer Narrative
The manufacturer previously reported was contacted alleging an issue related to an essence with ssd & ssr device's sound abatement foam.The patient has alleged cord caught on fire and burning smell was observed within the device.There was no report of serious or permanent harm or injury.No medical intervention was required by the patient.The device was evaluated by manufacturer's product investigation laboratory (pil) and customer's complaint was confirmed.Pil believes upon disassembly finding no physical evidence of thermal complaint.Pil found little-to-no amounts of contamination: dirt, dust, debris, and hair inside the device indicating possible tampering.Physical damage to the ac power cord appears to be the cause of the complaint.Section device serviced by 3rdp, device avail.For eval, date returned, in box d, device evaluated by mfg, evaluation method code grid (1), evaluation results code grid (1), conclusion code grid (1) in box h has been updated/corrected in this report.

• Brand Name: ESSENCE WITH SSD & SSR
• 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: 18964757
• Report Number: 2518422-2024-14936
• Device Sequence Number: 8161900
• Product Code: CAF
• UDI-Device Identifier: 00383730001821
• UDI-Public: 00383730001821
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K170853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: Other
• Device Model Number: 1100312
• Device Catalogue Number: 1100312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 79 YR
• Patient Sex: Male