MAUDE Adverse Event Report: MEDICAL INTELLIGENCE FRAXION; ACCELERATOR, LINEAR, MEDICAL

Model Number P10106-111

Device Problems Device Reprocessing Problem (1091); Split (2537); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

Fraxion mouthpiece snapped while patient positioning for treatment on treatment table.No injury or mistreatment sustained to patient.

Manufacturer Narrative

Brand name corrected from fraxion head support module st to fraxion.Model no, catalog no.And serial no.Supplied in initial report were for fraxion head support module st and not for fraxion.The component of fraxion that malfunctioned was fraxion mouthpiece small p2 and details of this part are provided.The component of the fraxion device that malfunctioned was fraxion mouthpiece small p2.Model/catalog no.P10106-323.Lot no.1198304.Udi: (b)(4).The manufacturer has completed its investigation and there are two aspects that have been identified that potentially contribute to the issue: the customer applied a chlorine based cleaning detergent for the mouthpiece.Chlorine based cleaning detergents are explicitly prohibited for application with the mouthpiece according to the user guide.A gluing step in the overall production process was missed.The actual root cause could not be identified.The internal technical investigation could demonstrate that even under a combination of different adverse circumstances the safety and effectiveness of the mouthpiece design is within acceptable limits.The customer has received a replacement device.

• Brand Name: FRAXION
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): MEDICAL INTELLIGENCE; medizintechnik gmbh; robert-bosch-str.8; schwabmunchen, 86830 ; GM 86830
• Manufacturer (Section G): MEDICAL INTELLIGENCE; medizintechnik gmbh; robert-bosch-str.8; schwabmunchen, 86830 ; GM 86830
• Manufacturer Contact: pms ; linac house; fleming way; crawley, RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 6344960
• MDR Text Key: 68132697
• Report Number: 9710332-2017-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physicist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P10106-111
• Device Catalogue Number: P10106-111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1