SONICATOR PLUS 940
Received May 20, 2013 · Event occurred Mar 1, 2013
Report 2013558-2013-00004 · MDR key 3131365
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
DEVICE WAS EVALUATED BY HOSPITAL BIO-MED AND NO PROBLEM WAS FOUND. THE DEVICE IS CURRENTLY BEING USED WITH NO FURTHER PATIENT INCIDENTS. THE DEVICE WILL NOT BE RETURNED TO METTLER FOR EVAL.
Description of Event or Problem
ON (B)(6) 2013, I RECEIVED A PHONE CALL FROM (B)(6). SHE STATED THAT A METTLER ME940 (S/N: (B)(4)) HAD ALLEGEDLY CAUSED BLISTERING TO TWO DIFFERENT PATIENTS. ON (B)(6) 2013, AFTER SEVERAL FAILED ATTEMPTS ON BOTH SIDES TO MAKE CONTACT, (B)(6), CONTACTED ME AND I WAS TOLD THAT THE UNIT WAS RUN IN IF MODE. THERE WERE TWO PATIENTS. WITH BOTH PATIENTS, UPON COMPLETION OF TREATMENT, NO WOUNDS WERE APPARENT. PATIENT CAME BACK THE NEXT DAY WITH AN INTACT BLISTER (2ND DEGREE BURN). PATIENT SOUGHT NO MEDICAL TREATMENT AND WOUND WAS HEALED WITHIN ONE WEEK.
Additional Manufacturer Narrative
DEVICE WAS EVALUATED BY HOSPITAL BIO-MED AND NO PROBLEM WAS FOUND. THE DEVICE IS CURRENTLY BEING USED WITH NO FURTHER PATIENT INCIDENTS. THE DEVICE WILL NOT BE RETURNED TO METTLER FOR EVAL.
Description of Event or Problem
ON (B)(6) 2013, I RECEIVED A PHONE CALL FROM (B)(6). SHE STATED THAT A METTLER ME940 (S/N: (B)(4)) HAD ALLEGEDLY CAUSED BLISTERING TO TOW DIFFERENT PATIENTS. ON (B)(6) 2013, AFTER SEVERAL FAILED ATTEMPTS ON BOTH SIDES TO MAKE CONTACT, (B)(6), CONTACTED ME AND I WAS TOLD THAT THE UNIT WAS RUN IN IF MODE. THERE WERE TWO PATIENTS. WITH BOTH PATIENTS, UPON COMPLETION OF TREATMENT, NO WOUNDS WERE APPARENT. PATIENT CAME BACK THE NEXT DAY WITH AN INTACT BLISTER (2ND DEGREE BURN). PATIENT SOUGHT NO MEDICAL TREATMENT AND WOUND WAS HEALED WITHIN ONE WEEK.
Remedial action
- Patient Monitoring