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

Model Number 1059751

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

The manufacturer received information on (b)(6) 2014 alleging a optionhome compressor had a broken plug at the back of the unit.There was no allegation of exposed wiring, harm or injury at the time of reporting.The unit was returned to rdd (b)(4) and evaluated on the (b)(6) 2014.The evaluation revealed exposed wires on the unit however the plug was found intact.(b)(4).

Manufacturer Narrative

Device received by rdd (b)(4) and evaluated.Reported complaint has been confirmed.Evaluation concluded that excessive force had been applied on power cord strain relief causing exposed wiring.The manufacturer concludes device has been inadequately maintained by the user according to the instructions for use and device has been replaced.

• Brand Name: OPTIONHOME COMPRESSOR
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): 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: 4071224
• MDR Text Key: 18038338
• Report Number: 9681154-2014-00025
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/04/2014

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: 1059751
• Device Catalogue Number: 1059751
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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