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

Model Number	1099973
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received this device for evaluation in response to a users report of "physical damage".There was no patient harm or injury reported.Upon receipt of the device, the manufacturer noted the ac cord plastic outer coating is split, exposing wires.The ac cord was taped up.The reported complaint of physical damage was confirmed.Labeling warns the "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 necessary.

• Brand Name: INNOSPIRE ELEGANCE
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way, tangmere; chichester, 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: rod mell ; chichester business park; city fields way, tangmere; chichester, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 12790574
• Report Number: 9681154-2021-00019
• Device Sequence Number: 11763546
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 180323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2018
• 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
• Patient Sex: Unknown