MAUDE Adverse Event Report: ELEKTA LTD PRECISE SERIES LINAC; ACCELERATOR, LINEAR, MEDICAL

Device Problems Electrical /Electronic Property Problem (1198); Moisture or Humidity Problem (2986); Positioning Problem (3009); Unintended Movement (3026)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's preliminary analysis: the hospital's incoming water temperature was 7 °c, which was lower than recommended in the site planning manual.As such, extreme condensation on cooling pipes collected on the ric and around the lvpsu resulted in dripping of water into the electronics.Site observations: · when entering a gantry angle or head angle the gantry/head started moving immediately, the move enable and auto enable were both high already.· the keypad items page left/page right(blue button)/auto enable (grey gantry asu) gave all and always a high on their corresponding part 4 · the start/interrupt/terminate buttons were still in a normal working state.Water ingress caused a false enable signal on hardware movements enable (hme) resulting in unexpected gantry and head movement, without requiring the asu to be pressed when the coordinates were entered.One occasion of "table clutch" was observed but disappeared after few minutes.There was no visible indication of water on the sk72f connector.The root cause for water temperature drop was identified as a failed 3-way valve on the hospital cooling circuit.Water appeared to have reached the bottom of the ric cabinet and affected the electronics which control the fkp.There was no way to check if the interface cabinet control area (icca) itself was faulty in this case.Initial corrective actions/preventive actions: onsite correction: · removed sk72f, this fixed page left function.· dried icca with hairdryers, replaced icca and all cables.All functions returned to normal state after this correction (0 on part 4 when not pressed).The failed 3-way valve on the hospital cooling circuit was also replaced.When working correctly, the system was then returned to clinical use.

Event Description

The customer reported that there was water on the reeling post interface cabinet (ric) due to condensation from the water pipes above.The condensation had dripped into the electronics, causing unexpected gantry and collimator rotation without the assisted set up (asu) buttons being activated on the function key pad (fkp).This incident was thought to have occurred during clinical use, however no patient or worker injury has been reported.

Manufacturer Narrative

The manufacturer's investigation concluded that the hospital's incoming water temperature was 7 °c, which was lower than recommended in the site planning manual.As such, extreme condensation on cooling pipes collected on the reeling interface cabinet and around the low voltage power supply unit resulting in dripping of water into the electronics.Site observations: · when entering a gantry angle or head angle the gantry/head started moving immediately, the move enable and auto enable were both high already.· the keypad items page left/page onsite correction: · removed (b)(4), this fixed page left function.· dried icca with hairdryers, replaced icca and all cables.All functions returned to normal state after this correction (0 on part 4 when not pressed).The failed 3-way valve on the hospital cooling circuit was also replaced.When working correctly, the system was then returned to clinical use.The start/interrupt/terminate buttons were still in a normal working state.Water ingress caused a false enable signal on hardware movements enable (hme) resulting in unexpected gantry and head movement, without requiring the asu to be pressed when the coordinates were entered.One occasion of "table clutch" was observed but disappeared after few minutes.There was no visible indication of water on the (b)(4) connector.The root cause for water temperature drop was identified as a failed 3-way valve on the hospital cooling circuit.Water appeared to have reached the bottom of the ric cabinet and affected the electronics which control the fkp.There was no way to check if the interface cabinet control area (icca) itself was faulty in this case.The manufacturer's risk assessment concluded the likelihood of failure of 3-way valve resulting in condensation causing the water drip on to electronics (which in turn causing fault on 2 signals) was assessed as improbable.This resulted in a tolerable risk value.Onsite correction: · removed (b)(4), this fixed page left function.· dried icca with hairdryers, replaced icca and all cables.All functions returned to normal state after this correction (0 on part 4 when not pressed).The failed 3-way valve on the hospital cooling circuit was also replaced.When working correctly, the system was then returned to clinical use.As this was an isolated case with a low likelihood of occurrence, no field safety corrective action was required.

Event Description

The customer reported that there was water on the reeling post interface cabinet (ric) due to condensation from the water pipes above.The condensation had dripped into the electronics, causing unexpected gantry and collimator rotation without the assisted set up (asu) buttons being activated on the function key pad (fkp).This incident was thought to have occurred during clinical use, however no patient or worker injury has been reported.

• Brand Name: PRECISE SERIES LINAC
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer (Section G): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer Contact: gpms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 4992030
• MDR Text Key: 24067454
• Report Number: 9617016-2015-00009
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K051932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Followup
• Report Date: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• 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