MAUDE Adverse Event Report: MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH CONNEXION IMAGING MODULE; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

Model Number	P10105-210
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported whilst positioning a patient, the middle section of the tabe top broke.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The broken imaging module was sent to the supplier for root cause analysis, however the breakage could not be determined.The risk assessment and the dynamic and static overload tests conclude that the current design is safe and no failures in the manufacturing process can be detected.The fraction pattern however, indicates a potential earlier dynamic overload which might have predamaged the board and most likely occurred in the field after installation.

• Brand Name: CONNEXION IMAGING MODULE
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH; robert-bosch-str. 8; schwabmunchen,, 86830 ; GM 86830
• MDR Report Key: 7410597
• Report Number: 9710332-2018-00001
• Device Sequence Number: 10772637
• Product Code: IXQ
• UDI-Device Identifier: 04056719001193
• UDI-Public: 04056719001193
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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
• Operator of Device: Health Professional
• Device Model Number: P10105-210
• Device Catalogue Number: P10105-210
• Device Lot Number: P10105-210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 170