MAUDE Adverse Event Report: OSSTEM IMPLANT XRAY2GO; PORTABLE X-RAY SYSTEM

Model Number XRAY2GO

Device Problem Fire (1245)

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

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer will conduct reinvestigation for this matter after receiving the subject devices from the distributor (dealer).The counter-plan meeting was held immediately as soon as it was reported from the distributor with the images and report.The supplier and manufacturer found that the battery was charged over 50% and the battery cell balance had been broken down from any external impact during delivery.But full investigation will be needed to determine the cause.The investigation will be conducted by international certified testing laboratory.The manufacturer requested the return of all of the same batch of the subject devices and stored warehouse devices except for the (b)(4) devices to the importer and distributor.The (b)(4) devices mentioned were different batch and sent to distributor upon their request.

Event Description

The distributor ((b)(4)) informed us of this incidence when it's happened at their warehouse.According to their narrative "they received a new batch of xray2go from hiossen out of (b)(4).It was a batch of (b)(4) units but unfortunately, one of the units, the external battery more specifically exploded and melted all the parts inside the box and burned the aluminum case as well.

• Brand Name: XRAY2GO
• Type of Device: PORTABLE X-RAY SYSTEM
• Manufacturer (Section D): OSSTEM IMPLANT; 135 gasan digital 2-ro. guemch; seoul, 15380 3; KS 153803
• Manufacturer (Section G): OSSTEM IMPLANT,SEOUL; 135 gasan digital 2-ro, geumch; seoul, 15380 3; KS 153803
• Manufacturer Contact: david kim ; 85 ben fairless dr.; fairless hills, PA 19030 ; 8886780001
• MDR Report Key: 6224686
• MDR Text Key: 64272189
• Report Number: 3012411108-2016-00002
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/18/2016

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: Dentist
• Device Model Number: XRAY2GO
• Device Lot Number: DXR1607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1