CONTOUR 24
Received Jun 23, 2023 · Event occurred Apr 29, 2023
Report 3007350713-2023-06191 · MDR key 17191593
Device
Generic name
Mri Rf Coil
Manufacturer
Quality Electrodynamics, LlcModel number
Q7000183Catalog number
Q7000183
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Female
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
QUALITY ELECTRODYNAMICS RECEIVED A COMPLAINT FORWARDED FROM SIEMENS THAT A CONTOUR 24 RF COIL CAUSED A PATIENT BURN. THE BURN WAS ON BACKSIDE OF RIGHT WRIST AND WAS A DIME - NICKEL SIZED BLISTER. THE PATIENT WAS WEARING SCRUBS PROVIDED BY THE HOSPITAL AND WAS NOT SEDATED. THE PATIENT DID NOT REQUEST THAT THE SCAN BE STOPPED. THE PATIENT CHOSE NOT TO SEEK ADDITIONAL MEDICAL CARE FOR THE BURN. THE CONTOUR COIL WAS BEING USED BY ITSELF (WITH NO OTHER COILS) AND WAS POSITIONED OVER THE PATIENT'S PELVIC REGION. PER THE TECHNOLOGIST'S MEMORY: 1. THERE WERE NO PADS BETWEEN THE PATIENTS LEGS. 2. THERE WAS PADDING BETWEEN THE COIL AND BORE. 3. IT IS UNKNOWN IF THERE WERE PADS BETWEEN THE PATIENT' HIPS AND ARMS. 4. IT IS UNKNOWN IF THERE WERE PADS BETWEEN THE PATIENT'S HAND AND THE COIL, BUT THE TECHNICIAN STATED THAT THE PATIENT'S HAND WAS NOT CONTACTING THE COIL AT THE BEGINNING OF THE SCAN. IT IS BELIEVED THAT THE PATIENT MAY HAVE INADVERTENTLY SHIFTED HER/THE COIL'S POSITION DURING THE SCAN, WHICH COULD HAVE CAUSED THE HARD HOUSING OF THE COIL TO CONTACT HER WRIST RESULTING IN THE BURN. THE COIL WAS RETURNED TO SIEMENS AND SUBSEQUENTLY TO QUALITY ELECTRODYNAMICS AFTER THE INCIDENT.
Remedial action
- Replace