6257 XPEDITION HIGH CONFIG
Received Nov 7, 2023 · Event occurred Oct 24, 2023
Report 0001831750-2023-01330 · MDR key 18087781
Device
Generic name
Transport, Patient, Powered
Manufacturer
Stryker Medical-kalamazooCatalog number
625705550002
Product problems
- Protective Measures Problem
- No Apparent Adverse Event
- Protective Measures Problem
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS INITIALLY REPORTED THAT THE CHEST BELT WAS BENT TO THE POINT WHERE IT COULD NOT BE LOCKED (INADEQUATE PATIENT RESTRAINT). FURTHER COMMUNICATION WITH THE CUSTOMER IDENTIFIED THAT THIS WAS REPORTED IN ERROR. THE CUSTOMER CONFIRMED THAT THERE WAS NO ISSUE WITH THE UNIT REPORTED UNDER THE INITIAL MDR.
Additional Manufacturer Narrative
FURTHER COMMUNICATION WITH THE CUSTOMER IDENTIFIED THAT THE COMPLAINT FOR THIS UNIT WAS SUBMITTED IN ERROR. THE CUSTOMER STATED THAT THERE WAS NO PROBLEM WITH THE RESTRAINTS. H3 OTHER TEXT : CUSTOMER CLARIFIED THAT THE ALLEGED DEFECT WAS REPORTED IN ERROR.
Description of Event or Problem
IT WAS REPORTED THAT THE CHEST BELT WAS BENT TO THE POINT WHERE IT COULD NOT BE LOCKED (INADEQUATE PATIENT RESTRAINT). NO ADVERSE CONSEQUENCE WAS ALLEGED TO HAVE OCCURRED AS A RESULT.