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

Model Number 1098909

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer Contact: alessandro agosti ; chichester business park; city fields way, tangmere; chichester, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 7425086
• MDR Text Key: 105273085
• Report Number: 9681154-2018-00009
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001975
• UDI-Public: 0383730001975
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 1098909
• Device Catalogue Number: 1109289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• 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