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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HITACHI, LTD, POWER SYSTEMS COMPANY, HITACHI WORKS PROBEAT; PROTON BEAM THERAPY SYSTEM
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HITACHI, LTD, POWER SYSTEMS COMPANY, HITACHI WORKS PROBEAT; PROTON BEAM THERAPY SYSTEM Back to Search Results
Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); Radiation Exposure, Unintended (3164)
Event Date 04/06/2015
Event Type  malfunction  
Event Description
The following event has occurred at a probeat iii installation in (b)(6).On (b)(6) the operator of the system found that irradiation occurred which was not consistent with the treatment plan and accordingly stopped the irradiation.On (b)(6) the pt was hospitalized for monitoring.On (b)(6) the pt was discharged from the hospital as no adverse effect was detected.No adverse health consequences have been reported to date.
 
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Brand Name
PROBEAT
Type of Device
PROTON BEAM THERAPY SYSTEM
Manufacturer (Section D)
HITACHI, LTD, POWER SYSTEMS COMPANY, HITACHI WORKS
3-1-1, saiwai-cho, hitachi-shi
ibaraki 317- 8511
JA  317-8511
Manufacturer Contact
1840 old spanish trail
houston, TX 77054
8325085043
MDR Report Key4726833
MDR Text Key5744633
Report Number3003993895-2015-00001
Device Sequence Number1
Product Code LHN
Combination Product (y/n)N
PMA/PMN Number
K073059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Remedial Action Notification
Type of Report Initial
Report Date 04/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/06/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3003993895-04/21/2015-00
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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