MAUDE Adverse Event Report: VECTURA GMBH AKITA JET

Model Number AKITA JET

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The product problem occurred during complaint investigation and device operation in order to investigate an akita jet device complaint that was received on (b)(6) 2015 and documented with ra_040_2015.The akita device was returned by the distributor in the netherlands to vectura (b)(4).The reason for return was low pressure performance of the device.Inspection within the service department revealed that the device tested ok using our power supply on the test bench.The device was then tested with the original power supply and an inhalation therapy of 40 min was simulated.After about 3 min a crackling sound was noted, coming from the power supply and a strong smell was detected.Visual inspection indicated deformation to the power supply casing within an area of about 6mm.The power supply was then opened and the printed circuit board was observed.In the area of the transformer several electrical components were destroyed by overheating.The casing was still intact.There was no patient or user injured and there was no report of further damage, fire or electric shock.

• Brand Name: AKITA JET
• Manufacturer (Section D): VECTURA GMBH; wohraer strasse 37; gemuendenwohra 0000 3528; GM 000035285
• Manufacturer Contact: bernhard mullinger ; robert-koch-allee 29; gauting 00008-2131 ; GM 000082131 ; 989796917
• MDR Report Key: 4951795
• MDR Text Key: 20726066
• Report Number: 3006894847-2015-00001
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/22/2015

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: Other
• Device Model Number: AKITA JET
• Device Catalogue Number: 01RS0100
• Device Lot Number: DC4913T POWER SUPPLY
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1