MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS VITALBEAM; LINEAR ACCERLERATOR

Model Number H194883

Device Problems Environmental Compatibility Problem (2929); Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/05/2023

Event Type  Injury  

Event Description

The patient's wife was dressing him after treatment.While she was putting on his shirt, the table suddenly rotated toward her and struck her right big toe causing a fracture.

Manufacturer Narrative

The patient's wife was dressing him after treatment.While she was putting on his shirt, the table suddenly rotated toward her and struck her right big toe causing a fracture.Investigation still in progress.

Manufacturer Narrative

Investigation determined that varian product worked as intended.It was, however, subjected to environmental conditions beyond operational specifications.Turntable pit had approximately 3cm of standing water, with evidence of having had up to approximately 10cm of standing water for an extended period.Issue was caused by unintended powering of brake at time that patient was applying force to couch in preparation to dismount.Definitive cause of unintended powering was not identified.Most likely issue was short between brake power line and +24v due to excessive moisture and damaged cables in the turntable area.No flooding incidents had been previously reported to varian until the event.Conduits and cables are not required to be waterproof or watertight.Upon questioning the customer, they reported that stand pit area had flooded several times before.However, they conveyed they did not know where the flooding was coming from or the root cause.At the time of this supplemental report the customer has been notified the this must be resolved to avoid recurrence.

Event Description

See completed mw-2023-00006.

• Brand Name: VITALBEAM
• Type of Device: LINEAR ACCERLERATOR
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 911 hansen way; palo alto CA 94304
• Manufacturer Contact: nia vanbalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 17802359
• MDR Text Key: 324111581
• Report Number: 2916710-2023-00005
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K213977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: H194883
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2023
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian