inforMED
MalfunctionNZD

STRETCHER

Received Nov 21, 2023

Report MW5148390 · MDR key 18193059

Device

Generic name

Stretcher, Patient Restraint

Patient

Unknown

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

Narrative

Description of Event or Problem

(B)(6) WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH (B)(6) IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED A MANUFACTURER STAXI CHAIR, SERIAL NUMBER (B)(6) THAT HAD A FOOTREST THAT WOULD NOT SUPPORT WEIGHT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).