MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE ELEGANCE; COMPRESSOR, AIR, PORTABLE

Model Number	1099973
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation that an innospire elegance device with a strange smell as if something is burning.There was no report of patient harm or injury.There was no report of medical intervention.The device has not been returned to the manufacturer.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 not returned to manufacturer.
Additional Manufacturer Narrative
Udi related data quality updates only: the manufacturer previously reported an allegation that an innospire elegance device with a strange smell as if something is burning.There was no report of patient harm or injury.There was no report of medical intervention.The device has not been returned to the manufacturer.The manufacturer's investigation is ongoing.The previous report stated the brand name as "innospire elegance".Section d1 has been updated with the brand name as "innospire elegance".The common device name was incorrectly reported as "nebulizing system, non-heated".Section d2 has been updated to "compressor, air, portable".The manufacturer date was incorrectly reported as "10/04/2021".Section h4 has been updated to "no information (ni)".
Additional Manufacturer Narrative
The manufacturer became aware of an allegation that an innospire elegance device with a strange smell as if something is burning.There was no report of patient harm or injury.There was no report of medical intervention.The device has not been returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.**udi related data quality updates only** the udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.

• Brand Name: INNOSPIRE ELEGANCE
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18185496
• Report Number: 2518422-2023-31271
• Device Sequence Number: 15088464
• Product Code: BTI
• UDI-Device Identifier: 00383730001715
• UDI-Public: (01)00383730001715
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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: 1099973
• Device Catalogue Number: 1099973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: Not provided; 10/23/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 07/11/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2021
• 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 Sex: Unknown