MAUDE Adverse Event Report: RESPIRATORY DRUG DELIVERY GROUP (UK) LTD. OPTIOHOME COMPRESSOR; COMPRESSOR, AIR, PORTABLE

Model Number 1059751

Device Problems Fire (1245); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

The manufacturer received information alleging an optionhome compressor emitted smoke and the patient claims to have seen flames from the power cord.There was no reported patient harm during this event.(b)(4).

Manufacturer Narrative

Patient allegedly discarded the device and is no longer available for evaluation, therefore, this complaint cannot be verified.The device is no longer being manufactured.The device is not life sustaining/supporting.

• Brand Name: OPTIOHOME COMPRESSOR
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRATORY DRUG DELIVERY GROUP (UK) LTD.; city fields way, tangmere; chichester business park; chichester, west sussex PO20 2FT; UK PO20 2FT
• Manufacturer Contact: alessandro agosti ; city fields way, tangmere; chichester business park; chichester, west sussex PO20 -2FT ; UK PO20 2FT ; 704231549
• MDR Report Key: 4482345
• MDR Text Key: 5330977
• Report Number: 9681154-2015-00001
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1059751
• Device Catalogue Number: 1059751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• 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