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

Model Number	1104624
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received an innospire elegance device for evaluation of "low air flow".There was no patient harm or injury reported.Upon receipt of the device, the manufacturer noted physical damage to the ac power source, which resulted in exposed conducting wires, and a risk of shock to the user.There was no evidence of thermal damage.Although the root cause of the observed damage was not confirmed, this type of damage is typically a result of the ac power cord being subjected to forces beyond intended design.The innospire elegance device is intended to provide a source of compressed air for medical purposes.It is to be used with a pneumatic (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".The user is also cautioned that the power supply cord cannot be replaced by the user.In case the power supply cord becomes damaged, contact philips respironics customer service for replacement (there is no service option).This device meets all relevant ul and iec standards.This device is not labeled for life support.The manufacturer will continue to monitor the complaint records for similar reported failures.Based on the available information, 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, uk PO20 2FT; UK PO20 2FT
• MDR Report Key: 8383088
• Report Number: 9681154-2019-00005
• Device Sequence Number: 2594239
• Product Code: CAF
• UDI-Device Identifier: 00383730003160
• UDI-Public: 00383730003160
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: KO42655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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: 1104624
• Device Catalogue Number: 1104624
• Device Lot Number: 160118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1