MAUDE Adverse Event Report: INNOSPIRE ESSENCE; COMPRESSOR, AIR, PORTABLE

Model Number	1112261
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received this device for evaluation in response to a users report of "faulty neb" and "power lead is damaged".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 reported complaints of "faulty neb" and "power lead is damaged" was confirmed.Labeling warns the user that the power supply cord (ac) cannot be replaced by the user.If the power cord becomes damaged, the user is instructed to contact their provider or the manufacturer for replacement, as there is no service option.This device meets all relevant ul and iec standards.Based on the information available, the manufacturer concludes no further action is necessary.
Additional Manufacturer Narrative
Manufacturing date should be 12/22/2020.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• MDR Report Key: 12713130
• Report Number: 9681154-2021-00020
• Device Sequence Number: 14628595
• Product Code: BTI
• UDI-Device Identifier: 00383730001951
• UDI-Public: 00383730001951
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/28/2021

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: 1112261
• Device Catalogue Number: 1112261
• Device Lot Number: 201222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• 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