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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MCLAREN HEALTH CARE MCLAREN PROTON THERAPY SYSTEM; SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL
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MCLAREN HEALTH CARE MCLAREN PROTON THERAPY SYSTEM; SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL Back to Search Results
Device Problems Computer Software Problem (1112); Energy Output Problem (1431)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  No Answer Provided  
Event Description
The (b)(6) therapy center delivered a wrong treatment dose of proton therapy to the patient because the software loaded a wrong treatment field.Fda safety report id # (b)(4).
 
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Brand Name
MCLAREN PROTON THERAPY SYSTEM
Type of Device
SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL
Manufacturer (Section D)
MCLAREN HEALTH CARE
MDR Report Key11071956
MDR Text Key223811983
Report NumberMW5098527
Device Sequence Number1
Product Code LHN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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