MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T

Model Number	ACHIEVA 1.5T R5 BASED
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a technician was injured during maintenance work on an achieva 1.5t mr system.An attraction incident took place causing fractures to fingers.

• Brand Name: ACHIEVA 1.5T
• Common Device Name: ACHIEVA 1.5T
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• MDR Report Key: 12525091
• Report Number: 3003768277-2021-10142
• Device Sequence Number: 5174586
• Product Code: LNH
• UDI-Device Identifier: 00884838055292
• UDI-Public: 884838055292
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: ACHIEVA 1.5T R5 BASED
• Device Catalogue Number: 781343
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other