MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARCADIS VARIC GEN2; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 10143406

Device Problem Use of Device Problem (1670)

Patient Problems Crushing Injury (1797); Injury (2348)

Event Date 11/06/2019

Event Type  Injury  

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

It was reported to siemens that an adverse event occurred while operating the arcadis varic gen 2 system.Due to an incorrectly positioned break handle, the operators fingers became pinched between the brake handle and the railing on the c-arm resulting in an injury.The operator was evaluated by a physician and reported slight tingling of the fourth and fifth digits.No medical treatment was required and the operator reported that the tingling subsided after one week.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a workmanship error.The investigation was performed considering complaint description, cs reports and system history.Prior to the incident, the handle was removed and put back on as part of service required during a maintenance activity.The engineer performed service activities not in accordance to established operator manual documentation.After preventive maintenance activities the function of the brakes must be checked in accordance with iec (b)(4).As this is the first occurrence of this error, the manufacturer will improve the service documentation regarding the position of the handles.

• Brand Name: ARCADIS VARIC GEN2
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, 91301 ; GM 91301
• MDR Report Key: 9353314
• MDR Text Key: 167344534
• Report Number: 3004977335-2019-07057
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K051133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10143406
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other