SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEM
Received Feb 28, 1995
Report MW5000020 · MDR key 34175
Device
Generic name
Fracture Healing System
Manufacturer
Exogen, Inc.Product problems
- No Device Output
- Material Separation
- Transducer failure
Patient
NO INFO
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A DEVICE FAILURE WAS REPORTED ON 2/10/95. A REPLACEMENT UNIT WAS SENT TO THE PT ON THE SAME DAY IN A PRIORITY OVERNIGHT SHIPMENT. UPON RETURN OF THE FAILED UNIT, VISUAL INSPECTION REVEALED THAT THE TRANSDUCER ELEMENT HAD SEPARATED FROM THE TRANSDUCER CUP. THIS CAUSED ONE OF THE TRANSDUCER INTERNAL CONNECTIONS TO SEPARATE. THIS PROBLEM CAUSED THE MAIN OPERATING UNIT (MOU) TO STOP OPERATING AND ACTIVATED THE TROUBLE ALARM AS THE SYSTEM WAS DESIGNED TO DO. THE TRANSDUCER HAS BEEN RETURNED TO THE MFR FOR EVALUATION OF THIS PROBLEM. THIS IS AN ISOLATED INCIDENT AND NO ACTION WILL BE INSTITUTED AT THE PRESENT TIME.