MAUDE Adverse Event Report: GARDNER DENVER THOMAS INC. INVACARE MOBILAIRE; NEBULIZER PUMP

Model Number IRC607

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/09/2014

Event Type  malfunction  

Event Description

The reported incident relates to a black gritty substance traveling through the tubing with each use.No injury is reported, at this time.

Manufacturer Narrative

Our examination of the returned unit indicated small amounts of black debris in the tubing and on some of the internal compressor head parts.We believed the debris was coming from our piston cup.We sent the returned tubing and a new piston cup to an outside lab (element materials technologies) to confirm if the material in the tubing was indeed coming from our piston cup.The lab analysis did in fact confirm that the black debris in the tubing was from the unit's piston cup.We next sent the returned tubing and a new piston cup to another outside lab (toxikon) to analyze the debris for toxicity.They conducted an agar diffusion test on both the tubing debris and the piston cup.The result indicated that after 48 hours there was no biological reactivity with the cell culture.Their final conclusion is that the residue in the tubing and the cup itself is not considered to have a cytotoxic effect.We believe that the piston cup prematurely degraded due to the fact that the compressor ingested some moisture.This would be an abnormal condition caused by improper use of the compressor or using the compressor in an improper environmental condition.Our complaint records lead us to believe that this type of improper use of our pump to be a rare incident.Based on this information and the fact that the piston cup material residue is not harmful we have elected nor to pursue this complaint any further than providing a replacing of the suspect unit.See scanned pages.

• Brand Name: INVACARE MOBILAIRE
• Type of Device: NEBULIZER PUMP
• Manufacturer (Section D): GARDNER DENVER THOMAS INC.; sheboygan WI 53081
• Manufacturer Contact: 1419 illinois ave.; sheboygan, WI 53081 ; 9204514252
• MDR Report Key: 4098806
• MDR Text Key: 18031998
• Report Number: 2182215-2014-00001
• 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: Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC607
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1