INVIVO
Received Oct 1, 2024 · Event occurred Sep 19, 2024
Report 1056069-2024-00002 · MDR key 20345772
Device
Generic name
Ds Shoulder Coil
Manufacturer
Philips Electronics Nederland B.v.Model number
DS SHOULDER 16CH 1.5TCatalog number
459801291131
Product problems
- Use of Incorrect Control/Treatment Settings
- Insufficient Device Problem Information
- Appropriate Device Problem Term/Code Not Available
- Use of Incorrect Control/Treatment Settings
- Insufficient Device Problem Information
- Appropriate Device Problem Term/Code Not Available
Patient
44 YR · Female
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
PHILIPS RECEIVED A REPORT THAT A PATIENT SUFFERED A BURN ON THE RIGHT SHOULDER WITH A BLISTER, DURING THE RIGHT SHOULDER EXAMINATION WITH THE SHOULDER COIL. BASED ON ADDITIONAL INFORMATION, IT WAS CLARIFIED THAT THE REDDENED AREA WAS 3-4 INCHES AND THE BLISTER WAS 1/2 TO 1 INCH.
Additional Manufacturer Narrative
PHILIPS HAS STARTED AN INVESTIGATION; A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative
PREVIOUS FOLLOW UP RECORD WAS COMPLETE AND NO ADDITIONAL FOLLOW UP REPORT WILL BE SENT FOR THIS REPORTED ISSUE. PLEASE REFER TO THE MFR REPORT NUMBER 1056069-2024-00002.