MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. INNOSPIRE ELEGANCE WITH SSR 230V50HZ, EU; COMPRESSOR, AIR, PORTABLE

Model Number	1099973
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received this device for evaluation from a distributor in (b)(6) for a report of "physical damage".Upon evaluation, the reported fault of physical damage was confirmed.There were exposed wires on the ac power cord.The root cause of this failure is typically due to the cord being exposed to forces beyond its intended design.The innospire elegance device is intended to provide a source of compressed air for medical purposes.It is to be used with apneumatic (jet) nebulizer to produce aerosol particles of medication for respiratory therapy for children and adults.Labeling warns the user "it is recommended to have a backup device for respiratory delivery in case a situation arises when your nebulizer can not be used".This device meets all relevant ul and iec standards.This device is not labeled for life support.Based on the information available, the manufacturer concludes no further action is required.

• Brand Name: INNOSPIRE ELEGANCE WITH SSR 230V50HZ, EU
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business part; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• MDR Report Key: 12306523
• Report Number: 9681154-2021-00015
• Device Sequence Number: 12012528
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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
• Device Lot Number: 180830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1