MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRIGHTVIEW; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number BRIGHTVIEW X

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/05/2023

Event Type  Injury  

Event Description

This complaint has been evaluated based on the information provided; there is an allegation of serious injury.This issue reported was a patient sustained a broken bone when their foot became trapped between the detector and the table.Based on the available information, this issue has been initially determined to be a reportable event.

Manufacturer Narrative

Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: (b)(4).

Manufacturer Narrative

Philips received a complaint regarding a brightview x spect system which reported that a patient sustained a broken bone when their foot became trapped between the detector and the patient support.With detector one at the 12 o'clock position facing downward and detector two at the 6 o'clock position facing upward, the patient was placed on the couch in the supine position.A total body pre-programmed motion (ppm) was initiated.As the table was moving upwards and the detectors were driving out to the start position, the patient experienced a cramp in his leg and straightened his foot out, causing it to extend beyond the couch.The operator did not notice the patient movement, and the patients foot become entrapped between the detector two bonnet and the couch.The system only has collision sensors on the face of the detector; therefore, the collision was not detected by the system and detector two continued to drive downward.The operator heard the patient and pressed the stop button on the hand controller; however, the button on the hand controller only stops an acquisition after it is started and does not stop motion during a ppm.When the stop button did not halt the detector motion, the technologist activated the emergency (e-stop) switch located at the end of the patient support which halted all system motion.The patient was removed from the system and taken to the emergency department, where he was diagnosed with a fracture and placed in a hard sole boot to immobilize the foot.The patient was released without any further treatment at that time.As per the brightview x ifu, the following warnings and cautions are mentioned: if the patient extends beyond the end of the imaging table, reposition the patient before starting any preprogrammed motion.Vigilantly watch the patient make sure that equipment or patient motion does not results in patient harm or equipment damage.If you perform a preprogrammed motion with the patient on the imaging table, monitor the equipment motion closely to avoid contact with the patient if any part of the system looks as if it is going to collide with the patient, use an emergency stop bottom to immediately stop the system motion when moving a patient using the hand-controller or the touchscreen, advice the patient not to move because they may be temporarily out of your line of view if you use ppm when a patient is on the imaging table, make sure that no part of the patient comes into contact with the gantry.Do not use the stop button on the hand-controller in an emergency.In an emergency, always use one of the four emergency stop buttons on the system.Although the stop button on the hand-controller stops the acquisition, this button is not intended to immediately stop all system motions.Conclusion: the system was confirmed to be operating per specifications and no failure was identified.This was observed from the log files and confirmed by fse.There are five illuminated e-stop buttons that stop all system motions when engaged.They are located on both sides of the gantry, the acquisition cart, the workstation and the patient table.This mitigation worked as expected.Multiple warnings and cautions are mentioned in the brightview x ifu about does/don¿ts for users while performing a clinical study.These instructions were not followed by the user during the clinical use of the system which resulted in patient injury.This issue was due to use error.

• Brand Name: BRIGHTVIEW
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: beth johnson ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 17048643
• MDR Text Key: 316384103
• Report Number: 3015777306-2023-00015
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,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: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BRIGHTVIEW X
• Device Catalogue Number: 882478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2011
• 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 Age: 72 YR
• Patient Weight: 70 KG