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

Model Number 1060509

Device Problem Fail-Safe Problem (2936)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

The manufacturer received information alleging a optionhome compressor had exposed wiring on the power cord of the device.No further incidence occured and no injury or death was reported during this event.The device has not been returned to the manufacturer for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: OPTIONHOME COMPRESSOR
• 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 ; UK
• Manufacturer Contact: alessandro agosti ; respiratry drug delivery groupo (uk); fields way, tangmere; chichester, west sussex ; UK ; 704231549
• MDR Report Key: 3972932
• MDR Text Key: 4751227
• Report Number: 9681154-2014-00006
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/04/2014

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?: No
• Device Operator: Other
• Device Model Number: 1060509
• Device Catalogue Number: 1060509
• Device Lot Number: 11M-0046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1