6257 XPEDITION HIGH CONFIG
Received Sep 29, 2023 · Event occurred Sep 2, 2023
Report 0001831750-2023-01010 · MDR key 17844939
Device
Generic name
Transport, Patient, Powered
Manufacturer
Stryker Medical-kalamazooCatalog number
625705550002
Product problems
- Difficult to Fold, Unfold or Collapse
- Difficult to Fold, Unfold or Collapse
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT WAS DIFFICULT TO FOLD/UNFOLD. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCE WERE ALLEGED.
Additional Manufacturer Narrative
THE B5 SUMMARY AND SECTION H CODES HAVE BEEN UPDATED TO REFLECT THE COMPLETED INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT WAS DIFFICULT TO FOLD/UNFOLD. FURTHER COMMUNICATION WITH THE SALES REP FOR THE ACCOUNT IDENTIFIED THAT NO DEFECT WAS ALLEGED WITH THE CHAIR BUT THAT THE CUSTOMER HAD BEEN TRYING TO UNFOLD THE UNIT WITHOUT ENGAGING THE RELEASE LEVER FIRST, CAUSING THE CUSTOMER TO EXPERIENCE INCREASED RESISTANCE AND TO DAMAGE THE CHAIR. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCE WERE ALLEGED.