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

Model Number RDD482

Device Problems Degraded (1153); Sparking (2595); Fail-Safe Problem (2936)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

The manufacturer received information alleging a minielite compressor had exposed wiring on the power cord of the device and allegedly sparked.No further incidence occurred and no injury or death was reported during this event.The device has not yet 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: MINIELITE 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 ; respiratory drug delivery group (uk); fields way, tangmere; chichester, west sussex ; UK ; 04/04/2014
• MDR Report Key: 3972921
• MDR Text Key: 4635068
• Report Number: 9681154-2014-00007
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• 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

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RDD482
• Device Catalogue Number: RDD482
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1