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

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Mclaren proton therapy system delivered an incorrect dose than prescribed due to an error in the software.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: 11125302
• MDR Text Key: 225564718
• Report Number: MW5098692
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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