MAUDE Adverse Event Report: MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH IGUIDE SYSTEM; ACCELERATOR, LINEAR, MEDICAL

Model Number	P10603-109 AND P10603-110
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer discovered during an in-house investigation that if the pec data dialog after a verification scan is cancelled, a re-send of pec data will lead to incorrect positioning because the 2nd pec values supersede the 1st pec values instead of being added.

• Brand Name: IGUIDE SYSTEM
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH; robert-bosch-strasse 8; schwabmuenchen, 86830 ; GM 86830
• MDR Report Key: 6633208
• Report Number: 9710332-2017-00002
• Device Sequence Number: 13455919
• Product Code: IYE
• UDI-Device Identifier: 04056719001742
• UDI-Public: 04056719001742
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Service Personnel
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/12/2017

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: Other
• Device Model Number: P10603-109 AND P10603-110
• Device Catalogue Number: P10603-109 AND P10603-110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1