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

Model Number IRC1710

Device Problem Burst Container or Vessel (1074)

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

Event Date 11/21/2014

Event Type  malfunction  

Event Description

It has been alleged that a invacare compressor "blew up into pieces" when she had turned the device on.There was no patient harm reported in this instance.(b)(4).

Manufacturer Narrative

Although it was alleged the device "blew up", no further information was available from the patient who hung up on the call to the reporter of the event before any further information could be acquired.There was no reported harm or injury.Device is not life sustaining/supporting.This device is no longer manufactured.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: COMPACT INVACARE COMPRESSOR
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRATORY DRUG DELIVERY (UK) LTD.; city fields way; chichester business park, tangmere; chichester, west sussex PO20 2FT; UK PO20 2FT
• Manufacturer Contact: alessandro agosti ; city fields way; chichester business park, tangmere; chichester, west sussex PO20 -2FT ; UK PO20 2FT ; 704231549
• MDR Report Key: 4360798
• MDR Text Key: 16635550
• Report Number: 9681154-2014-00042
• 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: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC1710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2014
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1