SYSTEM 2000
Received Jun 13, 2024 · Event occurred Apr 17, 2024
Report 3007420694-2024-00151 · MDR key 19527035
Device
Product problems
- Device Tipped Over
- Device Tipped Over
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ARJO WAS NOTIFIED OF AN EVENT INVOLVING A SYSTEM 2000 BATHTUB. IT WAS REPORTED THAT THE BATHTUB WAS BEING FILLED WHILE THE RESIDENT WAS INSIDE, PLACED ON AN ALENTI BATH CHAIR. IT WAS INDICATED THAT THE BATHTUB BEGAN TO TIP OVER WHILE THE RESIDENT WAS BEING WASHED. THE CAREGIVER PREVENTED THE BATHTUB FROM FALLING OVER. NO INJURIES WERE REPORTED. IT WAS INDICATED THAT THE BATHTUB WAS NOT BOLTED TO THE FLOOR. HOWEVER, SYSTEM 2000 BATH IS NOT REQUIRED TO BE BOLTED TO THE FLOOR AS PER ITS DESIGN. BASED ON THE DEVICE INSPECTION RESULTS, THE POST-MARKET SURVEILLANCE DATA AND INFORMATION GATHERED WE CAME TO THE CONCLUSION THAT THE ISSUE REPORTED SEEMS TO BE RELATED TO INCORECTLY USING OF THE DEVICE. NO MALFUNCTION WAS FOUND THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE FACILITY STAFF WANTED TO PUT THE RESIDENT INTO THE BATH FROM THE END OF THE BATHTUB, NOT AT THE SIDE AS INDICATED IN THE INSTRUCTION FOR USE (IFU) FOR SYSTEM 2000 BATH. THE CUSTOMER IS AWARE OF THE ISSUE AND WILL PROVIDE TRAINING FOR THE STAFF. THE SYSTEM 2000 BATH IFU (04.AR.12_11) INFORMS AND SHOWS HOW TO USE THE DEVICE: "POSITION LIFT HYGIENE CHAIR DIAGONALLY TO THE SIDE OF THE BATH WITH SUFFICIENT SIDEWAYS CLEARANCE". ACCORDING TO THE ABOVE THE DEVICE WAS FOUND TO HAVE BEEN TO SPECIFICATION WHEN THE EVENT TOOK A PLACE. THE BATH WAS USED WITH THE RESIDENT WHEN THE EVENT OCCURRED. THIS COMPLAINT WAS DECIDED TO BE REPORTED DUE TO BATH TIPPING OVER DURING USE.
Additional Manufacturer Narrative
PROCESS OF ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.
Description of Event or Problem
ARJO WAS NOTIFIED OF AN EVENT INVOLVING A SYSTEM 2000 BATHTUB. IT WAS REPORTED THAT THE BATHTUB WAS BEING FILLED WHILE THE RESIDENT WAS INSIDE, PLACED ON A BATH CHAIR. IT WAS INDICATED THAT THE BATHTUB BEGAN TO TIP OVER WHILE THE RESIDENT WAS BEING WASHED. THE CAREGIVER PREVENTED THE BATHTUB FROM FALLING OVER. NO INJURIES WERE REPORTED. THE SYSTEM 2000 BATH WAS NOT BOLTED TO THE FLOOR.
Additional Manufacturer Narrative
PROCESS OF COLLECTING AND ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.