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

Model Number 1100312

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

H3 other text : device evaluated by third party service center.

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
• Type of Device: 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
• MDR Text Key: 338402050
• Report Number: 2518422-2024-14936
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001821
• UDI-Public: 00383730001821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1100312
• Device Catalogue Number: 1100312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male