MAUDE Adverse Event Report: MCLAREN HEALTH CARE MCLAREN PROTON THERAPY SYSTEM; SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL

Device Problems Computer Software Problem (1112); Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

The mclaren proton therapy system delivered in incorrect dose to the patient due to a software issue.Fda safety report id# (b)(4).

• Brand Name: MCLAREN PROTON THERAPY SYSTEM
• Type of Device: SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL
• Manufacturer (Section D): MCLAREN HEALTH CARE
• MDR Report Key: 11278761
• MDR Text Key: 230538746
• Report Number: MW5099213
• Device Sequence Number: 1
• Product Code: LHN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• 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 Number: 1