inforMED
MalfunctionOKO

NEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUS

Received Aug 12, 2023

Report MW5137472 · MDR key 17530553

Device

Generic name

Negative Pressure Wound Therapy Non-powered Suction Apparatus

Manufacturer

Kalypto

Model number

P10001-K

Catalog number

034878

Lot number

000054-054

Product problems

  • Premature Discharge of Battery
  • Premature Discharge of Battery

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

FACILITY REPORTED THAT PUMP WAS USING TOO MANY BATTERIES; 3 PER DAY. THEY THOUGHT THE UNIT RAN WELL AND DID WHAT IT WAS SUPPOSED TO BUT IT WOULD DRAIN BATTERIES IN LESS THAN A DAY AND SHUT OFF. I REPLACED UNIT. NO INJURY ALLEGED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).