TREATMENT HEAD MODULE
Received May 5, 1995
Report MW5000006 · MDR key 22394
Device
Generic name
Treatment Head Module
Manufacturer
Exogen, Inc.Product problems
- Break
- Misassembled
- Material Separation
Patient
*
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
A REPLACEMENT UNIT WAS SENT TO THE PT ON 2/27/95 IN A PRIORITY OVERNIGHT SHIPMENT. UPON RETURN OF THE DEVICE IN QUESTION, IT WAS NOTED THAT THE TRANSDUCER CUP ASSEMBLY WAS LOOSE IN THE TRANSDUCER BARREL. THE ADHESIVE WHICH BONDS THE TRANSDUCER CUP TO THE BARREL HAD NOT BONDED AS EXPECTED. THE CONTRACT MFR HAD BEEN NOTIFIED OF THIS POSSIBILITY PRIOR TO THIS OCCURRENCE AND HAS TAKEN APPROPRIATE STEPS TO PREVENT THIS FROM RECURRING.