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

Model Number	1100312
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received an innospire essence device for evaluation due to a report of "physical damage".There was no patient involvement reported.Upon receipt, the manufacturer noted physical damage to the ac power cord, with exposure to the conducting wires.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 essence 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).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: ESSENCE
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way; tangmere, chichester P202 2FT; UK P202 2FT
• Manufacturer (Section G): RESPIRONICS RESPIRATORY DRUG DELIVER (UK) LTD.; chichester business park; city fields way; tangmere, chichester P202 2FT; UK P202 2FT
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14371548
• Report Number: 9681154-2022-00006
• Device Sequence Number: 5770037
• Product Code: BTI
• UDI-Device Identifier: 00383730001821
• UDI-Public: 00383730001821
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: 1100312
• Device Catalogue Number: 1100312
• Device Lot Number: 190307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2019
• 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