6257 XPEDITION MID CONFIG
Received Jan 28, 2025 · Event occurred Oct 1, 2024
Report 0001831750-2025-00183 · MDR key 21257996
Device
Generic name
Transport, Patient, Powered
Manufacturer
Stryker Medical-kalamazooCatalog number
625705550001
Product problems
- Protective Measures Problem
- Sharp Edges
- Protective Measures Problem
- Sharp Edges
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
VMSR ADDED TO EXEMPTION NUMBER FIELD.
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE WAS REPAIRED AND RETURNED TO USE. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.