inforMED
MalfunctionDXN

MEDLINE

Received Jul 13, 2026 · Event occurred Mar 9, 2023

Report 1417592-2026-05447 · MDR key 25804572

Device

Generic name

Monitor,bp,auto,digital,adult & Lg Adult

Catalog number

MDS3001PLUS

Product problems

  • Failure to Power Up

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT PT RECIVED BP, PT PUT IN NEW BATTERIES WHEN TRYING TO TURN ON ITEM, UNIT IS NOT TURNING ON.

Additional Manufacturer Narrative

IT WAS REPORTED THAT PT RECIVED BP, PT PUT IN NEW BATTERIES WHEN TRYING TO TURN ON ITEM, UNIT IS NOT TURNING ON. 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. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS PART OF RETROSPECTIVE REVIEW ACTIVITIES, WHICH INCLUDE REVIEW OF HISTORICAL DATA IN ACCORDANCE WITH REGULATIONS AT 21 CFR PART 803. THE INFORMATION INCLUDED IN THIS MDR REFLECTS THE INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THE TIME OF THIS RETROSPECTIVE REVIEW AND SUBMISSION.