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

Model Number HS456

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation, so we are unable to confirm the complaint.The caregiver has, however, provided us with two photographs of the device, neither of which indicate any fire or thermal event occurred.These devices are no longer in production.

Event Description

It was reported that this device sparked and that there was a flame in the motor on the inside of the unit.(b)(4).

• Brand Name: INSPIRATION ELITE
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, west sussex PO20 2FT; UK PO20 2FT
• Manufacturer Contact: alessandro agosti ; chichester business park; city fields way, tangmere; chichester, west sussex PO20 -2FT ; UK PO20 2FT ; 704231549
• MDR Report Key: 6456037
• MDR Text Key: 71575502
• Report Number: 9681154-2017-00005
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2017

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: HS456
• Device Catalogue Number: HS456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR