MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SIGNATURE E.CAM DUAL CAMERA, B; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number 07823946

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Head Injury (1879)

Event Date 02/01/2024

Event Type  Injury  

Event Description

Siemens medical solutions usa, inc.Was notified on (b)(6) 2024 of a patient injury that occurred on (b)(6) 2024.The date of awareness of the severity of the injury was received on (b)(6) 2024 during a cardiac imaging exam, a patient turned over and fell off the imaging bed to the floor, resulting in injuries to the hip, head trauma and a fractured c3 vertebra.During this exam, the system was operated contrary to use instructions.Non-siemens accessories were used.Third party wraps were not secured to the imaging pallet.Velcro on the pallet was deteriorated.A third party pad was placed on pallet, which was too thick and did not contour to the pallet.The patient was not positioned according to use instructions and best clinical practice and was positioned in a non-standard technique for cardiac imaging.There are no product defects or failures.There are no labeling defects.Product labeling includes instructions that the body wrap is used for patient positioning, specifically to immobilize the patient¿s arms and/or upper torso.There were no other injuries to any other persons.

Manufacturer Narrative

Siemens medical solutions usa, inc.Was notified on (b)(6) 2024 of a patient injury that occurred on (b)(6) 2024.The date of awareness of the severity of the injury was received on (b)(6) 2024.During a cardiac imaging exam, a patient turned over and fell off the imaging bed to the floor, resulting in injuries to the hip, head trauma and a fractured c3 vertebra.During this exam, the system was operated contrary to use instructions.Non-siemens accessories were used.Third party wraps were not secured to the imaging pallet.Velcro on the pallet was deteriorated.A third party pad was placed on pallet, which was too thick and did not contour to the pallet.The patient was not positioned according to use instructions and best clinical practice and was positioned in a non-standard technique for cardiac imaging.There are no product defects or failures.There are no labeling defects.Product labeling includes instructions that the body wrap is used for patient positioning, specifically to immobilize the patient¿s arms and/or upper torso.There were no other injuries to any other persons.

• Brand Name: SIGNATURE E.CAM DUAL CAMERA, B
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2501 n. barrington rd.; hoffman estates IL 60192
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2501 n. barrington rd.; hoffman estates IL 60192
• Manufacturer Contact: laura meyer ; 2501 n. barrington rd.; hoffman estates, IL 60192 ; 8472172734
• MDR Report Key: 18748406
• MDR Text Key: 335933534
• Report Number: 1423253-2024-00001
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142006
• 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
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 07823946
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Date Device Manufactured: 07/25/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 93 YR
• Patient Sex: Male