MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE BIPLANE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094141

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

Siemens became aware of an incident that occurred while operating the artis zee biplane system.Cover of the ceiling caterpillar, where the cable to the laboratory monitor suspension (dcs) passes through, detached and fell down.Siemens has requested additional information in order to conduct an investigation of the reported event.The reported incident occurred in (b)(6).

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.An unused empty conduit, which was attached to the ceiling of the examination room in the movable cable duct, and which was compressed by mechanical movements, led to the detachment of some small plastic links of the movable cable duct.These light plastic links fell off and were ultimately the cause of the problem.Such a defect can only be repaired by an on-site service visit.The empty conduit was an unused one, which served for possible replacement purposes of the cable routing, therefore, it was removed, and the cause of the defect was eliminated.The loosened plastic links of the cable duct were reused and inserted into the energy chain.After the service intervention, the system again functioned as specified and the error has not been reported again.A possible accumulation of faults or even a general fault that would require corrective measures of the installed base could not be determined by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11059566
• MDR Text Key: 224276111
• Report Number: 3004977335-2020-58802
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: 04056869010069
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other