MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE ELEGANCE NEBULIZER; COMPRESSOR, AIR, PORTABLE

Model Number 1099969

Device Problem Fire (1245)

Patient Problem Dyspnea (1816)

Event Date 09/20/2013

Event Type  Injury  

Event Description

The mfr received info alleging a nebulizer caused a fire in a pt's home.The pt extinguished the fire but experienced shortness of breath.The pt went to the emergency room where she was treated and released.The device has not yet been returned to the mfr for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the mfr's investigation is complete.

• Brand Name: INNOSPIRE ELEGANCE NEBULIZER
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; murrysville PA
• Manufacturer Contact: alessandro agosti, manager ; city fields way, tangmere; chichester business park; chichester, west sussex PO20 -2FT ; UK PO20 2FT ; 8704231549
• MDR Report Key: 3591183
• MDR Text Key: 16554031
• Report Number: 9681154-2014-00001
• Device Sequence Number: 1
• Product Code: BTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1099969
• Device Catalogue Number: 1099969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1