MEDLINE
Received Jul 17, 2026 · Event occurred Jun 19, 2026
Report 1417592-2026-06138 · MDR key 25864461
Device
Generic name
Monitor,bp,auto,digital,universal
Manufacturer
Medline Industries, LpCatalog number
MDS5001
Lot number
L240680006
Product problems
- Device Provides Uninformative Message
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE DEVICE WAS SHOWING AN ERROR CODE. "CUSTOMER SPOKE WITH PRODUCT SUPPORT FOR TROUBLESHOOTING. SHE IS USING HER MONITOR FOR THE FIRST TIME AND CALLED TO REQUEST ASSISTANCE WITH SETTING THE DATE AND TIME. AFTER SETTING THE DATE AND TIME, WALKED HER THROUGH HOW TO APPLY THE CUFF AND TAKE A MEASUREMENT. EDUCATED CUSTOMER ON NEEDING TO MAKE THE CUFF SNUG AND WHERE TO PLUG IT IN. TRIED TAKING A MEASUREMENT BUT COULD NOT GET ONE. TRIED AT LEAST SIX TIMES AND THE MONITOR GAVE AN ERU ERROR EACH TIME. CONFIRMED WITH THE CUSTOMER THAT THE CUFF WAS SNUG AND FIRMLY PLUGGED IN." THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS SHOWING AN ERROR CODE.