MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA

Model Number	INGENIA 1.5T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was positioned on the table top on the mri flex track by 2 operators.Then the patient and the flex track and table top were positioned above the base of the mri bed.After this the mri bed was raised up.During this upward movement of the bed the patient left her hand hanging between the flex track and the base of the mri bed.This was not noticed by the operators, as a result a finger got pinched and part of it was cut off.It was stated by the operators that they were watching the patient from either side of the mri bed but that they had not noticed the exact position of the patients hand due to the patient being covered by sheets.

• Brand Name: INGENIA
• Common Device Name: INGENIA
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• MDR Report Key: 11146413
• Report Number: 3003768277-2021-00005
• Device Sequence Number: 836770
• Product Code: LNH
• UDI-Device Identifier: 00884838099715
• UDI-Public: 00884838099715
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• 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: Health Professional
• Device Model Number: INGENIA 1.5T
• Device Catalogue Number: 781315
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/11/2021
• 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: Required Intervention