MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD ELEGANCE; COMPRESSOR, AIR, PORTABLE

Model Number	1099973
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Unspecified Respiratory Problem (4464)
Date of Event	09/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information from (b)(6) regarding an allegation an innospire elegance compressor began emitting thick smoke while in use.The user was reportedly hospitalized with oxygen desaturation and unspecified respiratory problems.The user was discharged the same day with a normal oxygen saturation and no after effects from the reported event.The manufacturer's investigation is on-going.Return of the device for investigation has been requested.A follow up report will be submitted upon completion of the manufacturer's investigation.
Additional Manufacturer Narrative
The manufacturer received the device for evaluation.The reported fault of thick smoke was not confirmed.The device operated as designed, no smoke was emitted.There was no warping to the inside or outside of the nebulizer case.There were no signs of black, smoke evidence inside the case or thermal damage.The manufacturer observed slight signs of ingress (spilled water or medication) inside the unit.The output pressure was within specification.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: ELEGANCE
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; cichester, PO20 2FT; UK PO20 2FT
• Manufacturer (Section G): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• Manufacturer Contact: kimberly shelly ; chichester business park; city fields way, tangmere; chichester, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 12618957
• Report Number: 9681154-2021-00016
• Device Sequence Number: 14320963
• Product Code: BTI
• UDI-Device Identifier: 00383730001715
• UDI-Public: 00383730001715
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1099973
• Device Catalogue Number: 1099973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2017
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown