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

Model Number INGENIA 3.0T CX

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Multiple Fractures (4519)

Event Date 10/06/2022

Event Type  Injury  

Event Description

Philips received a report that a patient suffered a broken rib during a breast examination.

Event Description

Philips received a complaint related to a breast examination on a ingenia 3.0t system.During the breast examination, the patient got caught in the bore and fractured the ribs.

Manufacturer Narrative

H3 other text : use error, patient did not fit in bore.

• 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 st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15624442
• MDR Text Key: 301910053
• Report Number: 3003768277-2022-00542
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838068452
• UDI-Public: 884838068452
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K162931
• Number of Events Reported: 1
• 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

• Date FDA Received: 10/18/2022
• 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
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: No
• 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