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U.S. Department of Health and Human Services

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

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PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 3.0T Back to Search Results
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.
 
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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 Key17622078
MDR Text Key321917539
Report Number3003768277-2023-04633
Device Sequence Number1
Product Code LNH
UDI-Device Identifier00884838068452
UDI-Public884838068452
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K162931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberINGENIA 3.0T CX
Device Catalogue Number781271
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/15/2023
Initial Date FDA Received08/25/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/23/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
Patient Weight69 KG
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