MAUDE Adverse Event Report: SIEMENS GMBH MEDICAL SOLUTIONS ARTUSTE NV SYSTEM

Model Number 08139789

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

Siemens became aware on (b)(6) 2015 that the chain master linker was broken during gantry rotation.As a consequence, the actuator ram was also broken due to the open chain with loose ends when the gantry rotation continued.There is no report of injury to a patient or facility personnel.This reported incident occurred in (b)(6).

Manufacturer Narrative

Investigation showed that the material of the complaint part was too soft and not as specified and parts from service stock also fail to meet the specification.However, the tensile test of the chain-actuator combination and the calculated proof of safety showed that the parts used are strong enough for usage with the system, including the softer material of the actuator.Specifications for the chain-actuator combination (associated parts used) and the relevant maintenance instructions will be updated.

• Brand Name: ARTUSTE NV SYSTEM
• Manufacturer (Section D): SIEMENS GMBH MEDICAL SOLUTIONS; roentgenstrasse 19021; kemnath 95478 ; GM 95478
• Manufacturer Contact: marlynee galloway ; 51 valley stream pkwy.; ms - d02; malvern, PA 19355-1406 ; 6102195361
• MDR Report Key: 4834675
• MDR Text Key: 5943641
• Report Number: 2240869-2015-02433
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08139789
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CHAIN MASTER LINKER; ACTUATOR RAM