SMART CHECK¿ BY ROHO®
Received Dec 5, 2019 · Event occurred Nov 5, 2019
Report 1419507-2019-00008 · MDR key 9419201
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
THE CUSTOMER ADVISES THAT THEY ARE CURRENTLY SEEING A WOUND CARE SPECIALIST FOR THEIR ALLEGED INJURY. THE CUSTOMER'S CONDITION IS IN THE PROCESS OF HEALING AND HAS NOT BEEN REPORTED AS WORSENING. BOTH THE SMART CHECK DEVICE AND THE CONCOMITANT CUSHION WERE RETURNED AND EVALUATED BY THE EXAMINING QUALITY ENGINEER. NO MANUFACTURING DEFECTS WERE FOUND WITH EITHER PRODUCT AND ALL TEST FOR FUNCTIONALITY WERE PASSED. THE CUSTOMER STATES THAT THEY ATTEMPTED TO UTILIZE THE DEVICE ACCORDING TO SPECIFICATIONS, BUT IT IS A PRODUCT THAT IS UNFAMILIAR TO THEM WHICH MAY HAVE CONTRIBUTED TO THE ERROR. ALTHOUGH AN ALLEGED INJURY HAS BEEN REPORTED, NO MEDICAL RECORDS HAVE BEEN SUBMITTED FOR CONFIRMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
PER CUSTOMER REPORT, "THIS ROHO SMART CHECK HAS TURNED A SMALL PRESSURE SORE TO A REAL PROBLEM. I CHECKED THE GAUGE DAILY, AND IT ALWAYS READ "GREEN" (WHICH IS OK), HOWEVER AT SOME POINT, I BOTTOMED OUT ON MY WHEELCHAIRS HARD SEAT BASE, EVEN THOUGH IT STILL READ "GREEN". I DID DO A PHYSICAL CLEARANCE TEST TO ENSURE I WAS NOT BOTTOMED OUT WHEN I FIRST BEGAN USING THIS CUSHION."
Remedial action
- Other