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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IBA (ION BEAM APPLICATIONS) PROTEUSPLUS PROTON THERAPY SYSTEM

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IBA (ION BEAM APPLICATIONS) PROTEUSPLUS PROTON THERAPY SYSTEM Back to Search Results
Model Number PROTEUS 235
Device Problems Detachment Of Device Component (1104); Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
Event Type  Malfunction  
Manufacturer Narrative

Evaluation summary is provided in (describe event or problem).

 
Event Description

Description of the event: on (b)(6) 2018, a patient unexpectedly received water on him while he was being aligned in the treatment room, with the gantry at 0° angle (nozzle above the patient). Impact of the event on the patient: the patient was not injured. He was able to remove himself from the table with assistance from clinical staff who received water on them as well. The patient was exposed to the water for two minutes at most. He received general cooling water (not hot water) on his legs. The water did not hit the patient's face or any mucous. Evaluation summary: it is estimated that the general cooling tank lost a total of 95 gallons of water in this leak. Investigation showed that the water came from a cooling hose that became detached from the cooling block of a quadripole magnet used for pencil beam scanning treatment mode. The hose clamp that secures the cooling hose to the cooling block was too far up the nipple to properly bite down on the barb of the nipple to prevent the pressure of the general cooling circuit from dislodging the cooling hose from the block.

 
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Brand NamePROTEUSPLUS
Type of DevicePROTON THERAPY SYSTEM
Manufacturer (Section D)
IBA (ION BEAM APPLICATIONS)
chemin du cyclotron 3
louvain-la-neuve, 1348
BE 1348
Manufacturer Contact
sylviane berger
chemin du cyclotron 3
louvain-la-neuve, 1348
BE   1348
10 203787
MDR Report Key7487371
MDR Text Key108001135
Report Number3000256071-2018-00002
Device Sequence Number1
Product Code LHN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082416
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Repair
Type of Report Initial
Report Date 04/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPROTEUS 235
Device Catalogue NumberPROTEUS 235
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/24/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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