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	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report on a heating incident on an achieva 1.5t mr system.A male patient was positioned feet first supine to undergo a knee examination with the sense-knee-8 coil.Patient reported blister on the left thigh one hour after the examination.
Additional Manufacturer Narrative
05-sep-2024 correction was made to the date received by mfg.

• 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
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 13709248
• Report Number: 3003768277-2022-00101
• Device Sequence Number: 15024459
• Product Code: LNH
• UDI-Device Identifier: 00884838055292
• UDI-Public: 884838055292
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2024

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: Health Professional
• Device Model Number: ACHIEVA 1.5T R5 BASED
• Device Catalogue Number: 781343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 02/09/2022; 02/09/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/04/2022; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 60 KG