MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 3.0T

Model Number INGENIA 3.0T CX

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem Multiple Fractures (4519)

Event Date 07/05/2023

Event Type  Injury  

Manufacturer Narrative

Philips has started an investigation, a follow up will be sent when complete.

Event Description

Philips received a report that a female patient suffered broken ribs during positioning for a mammo mri.

Manufacturer Narrative

The root cause for these events is that the space between patient/breast coil combination and mr system magnet bore is narrow and a patient might get squeezed/experiences friction between the breast coil and the top of the bore.In addition, for performing a breast examination using the breast coils, a patient is placed on top of the breast coil (face down), thereby creating pressure points to the patient chest (ribs and sternum), which in case of compromised bone strength (e.G., due to breast cancer, bone abnormalities or metastasis) might lead to fractures.The successful positioning of patients in the bore using the mr breast coil depends on several factors, such as patient size, weight distribution, and body shape, etc.Safe patient positioning needs to be individually assessed and ensured for each patient prior to the actual scan.The instructions for use (ifu) contains the following information/warning for users/operators: ¿when using breast coils if the patient¿s back touches the bore and stops the table movement.Do not manually force the table to the iso center, this could cause injury to the patient.¿ in addition, this ifu has the following statement: ¿when positioning the coil on the table and the patient in the coil, always check that the coil and/or the patient will not hit the bore when moving the table, this could result in patient injury.Refer to the system instructions for use for positioning instructions.¿ conclusion it is always the responsibility of the operator to position a patient in such a way that no patient body parts, device accessories, or cables can get stuck or caught during table movement.The movement of the patient into the system is done via continuous operation and can be stopped at any time immediately by the operator.Instructions for use has warnings related to this topic.

• Brand Name: INGENIA 3.0T
• Type of Device: INGENIA 3.0T
• 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 ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 17622077
• MDR Text Key: 321917486
• Report Number: 3003768277-2023-04635
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838068452
• UDI-Public: 884838068452
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INGENIA 3.0T CX
• Device Catalogue Number: 781271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 84 KG