MAUDE Adverse Event Report: RESPIRONICS, INC.. INSPIRATION ELITE-UK; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 1054194

Device Problems Sparking (2595); Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2022

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation from a customer that an inspiration elite nebulizer had short circuited, and the home power shut off.Sparks from the device caused burn marks on the bed sheet.There was no patient harm or injury reported.The nebulizer has not yet been returned for investigation.The investigation is on-going.A follow up final will be filed once the investigation is complete.

Manufacturer Narrative

The manufacturer previously reported that they became aware of allegations from a customer that an inspiration elite nebulizer had short circuited, and the home power shut off.Sparks from the device caused burn marks on the bed sheet.There was no patient harm or injury reported.Communication was received stating that the device was misplaced so they will return the device if they have found it.No product has been returned despite additional attempts to request the return of the nebulizer.The manufacturer could not confirm the allegation from the customer that the nebulizer had short circuited, the home power shut off and sparks from the device caused burn marks on the bed sheet.This will be submitted as a final report.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

• Brand Name: INSPIRATION ELITE-UK
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS, INC..; 1001 murry ridge lane; city fields way, tangmere; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC..; 1001 murry ridge lane; city fields way, tangmere; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; city fields way, tangmere; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13333085
• MDR Text Key: 284288000
• Report Number: 9681154-2022-00001
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1054194
• Device Catalogue Number: 1054194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male