MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T DSTREAM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number SMARTPATH TO DSTREAM FOR 1.5T

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient's finger was caught in the door of the examination room, resulting in a laceration.The laceration was treated with sutures.The examination room door is not part of the philips device, it is also not a medical device but is manufactured according to specifications in the philips planning reference data document.There is no finger pinching protection available for the door which, considering the weight of the door, is also not feasible.Based on all available information, the harm to the patient occurred due to the exam room door and not with a philips device.However, out of an abundance of caution, it was decided to report this event.H3 other text : examination room door is not part of device.

Event Description

Philips received a report that a 90 year old female had her finger caught in the door of the examination room.The patient sustained lacerations to her finger that required stiches.

• Brand Name: ACHIEVA 1.5T DSTREAM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• 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: 18675568
• MDR Text Key: 335008555
• Report Number: 3003768277-2024-00781
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063559
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SMARTPATH TO DSTREAM FOR 1.5T
• Device Catalogue Number: 781260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female