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

Model Number IRC1710

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

The manufacturer received information on (b)(4) 2014 alleging a compact invacare compressor had exposed wires.There was no reported harm or injury to the patient.(b)(4).

Manufacturer Narrative

The device was not returned to the manufacturer for investigation; therefore we are unable to determine if there is a risk for electrical shock.With the information provided, this investigation remains inconclusive.No further follow-up reporting will be provided for this issue unless new information becomes available.

• Brand Name: COMPACT, INVACARE
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way, tangmere; chichester, west sussex P020 2FT; UK P020 2FT
• Manufacturer Contact: alessandro agosti ; chichester business park; city fields way, tangmere; chichester, west sussex PO20 -2FT ; UK PO20 2FT ; 704231549
• MDR Report Key: 4308235
• MDR Text Key: 17936106
• Report Number: 9681154-2014-00034
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042483
• 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: 10/24/2014

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: IRC1710
• Device Catalogue Number: IRC1710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1