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

Model Number	1098909
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to date, however, photos of the damaged device battery have been received from the device distributor.These clearly indicate that thermal damage has occurred to the battery, but do not offer any indication as to the cause.
Event or Problem Description
The patient reported a damage claim to their insurance company that there was property damage.The patient states that the device was charging, and then exploded.There was a small fire which caused some smoke damage and some burn marks in the carpeting.Internal reference ra (b)(4).

• Brand Name: INNOSPIRE MINI
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• MDR Report Key: 7425086
• Report Number: 9681154-2018-00009
• Device Sequence Number: 1542865
• Product Code: CAF
• UDI-Device Identifier: 00383730001975
• UDI-Public: 0383730001975
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2018

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: 1098909
• Device Catalogue Number: 1109289
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1