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

Model Number 1060509

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 10/20/2014

Event Type  No Answer Provided  

Event Description

The mfr received info alleging a pt had rested an optionhome compressor on their thigh and thereafter burnt the pt.Pt stated that they sought med attention from a dr at the nursing facility.The device has not yet been returned to the mfr for eval.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.(b)(4).

• Brand Name: OPTIONHOME COMPRESSOR
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY GROUP (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: 4283630
• MDR Text Key: 5083403
• Report Number: 9681154-2014-00035
• 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: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1060509
• Device Catalogue Number: 1060509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1