MalfunctionCCX
VITAL SIGNS HEAD POSITIONER
Received Mar 14, 2020 · Event occurred Feb 13, 2020
Report 9613793-2020-00010 · MDR key 9832691
Device
Generic name
Head Positioner
Manufacturer
Vyaire Medical.Model number
VITAL SIGNS HEAD POSITIONERCatalog number
8000HDP
Lot number
48927702
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED YET. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE 8000HDP VITAL SIGNS HEAD POSITIONER HAS SPLIT AT THE SIDE DURING SURGERY. AS OF THIS TIME, THE INFORMATION REGARDING PATIENT HARM HAS NOT BEEN PROVIDED.