MalfunctionKPX
AMBER-CU
Received May 30, 1997 · Event occurred Jan 17, 1997
Report 1180516-1997-00002 · MDR key 96422
Device
Generic name
Clinical Chests Stand (upright)
Manufacturer
Oldelft B.v.Model number
AMBER-CUCatalog number
104L001
Lot number
NA
Patient
*
Narrative
Description of Event or Problem
AS A RESULT OF WEAR IN LIFTING MECHANISM THE HORIZONTAL ARM OF THE DEVICE MOVED DOWN FOR APPROX 10 CM. NO PT INJURIES ARE REPORTED. SUBSEQUENTLY DURING SERVICE THE ARM DESCENDED ANOTHER 10 CM. SUBSEQUENT INVESTIGATION INDICATED THAT THE MAINTENANCE PROCEDURE FOR THE REGULAR CHECK ON THE LIFTING MECHANISM HAD NOT BEEN PERFORMED AS REQUIRED BY THE MAINTENANCE INSTRUCTIONS.
Remedial action
- Inspection
- Modification/Adjustment
- Notification