SYSTEM 2000
Received Nov 16, 2023 · Event occurred Oct 20, 2023
Report 3007420694-2023-00275 · MDR key 18146688
Device
Product problems
- Unintended Movement
- Unintended Movement
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE INSPECTION PERFORMED BY AN ARJO TECHNICIAN REVEALED THAT THE PRINT CIRCUIT BOARD (PCB) FAILED. WHEN HE OPENED THE BOX BEHIND THE PANEL, THERE WAS WATER INSIDE. HE COULD NOT DETERMINE EXACTLY WHERE THE WATER HAD GOTTEN INSIDE, AS THERE WERE NO CRACKS ON THE PANEL OR THE COVER OF THE BOX. THE CONTROL PANEL AND PCB WERE REPLACED. THE INVESTIGATION IS ONGOING AND FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.
Description of Event or Problem
ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF SYSTEM 2000 BATH. IT WAS REPORTED THAT WHILE THE PATIENT WAS SITTING INSIDE THE BATH, THE BATH STARTED TO RAISE UNINTENDED, WHEN THE CAREGIVER PRESSED THE SHOWER HANDLE BUTTON. TWO SECONDS AFTER THAT, THE BATH STOPPED. NO INJURIES TO THE PATIENT WERE REPORTED.
Additional Manufacturer Narrative
THE DEVICE INSPECTION PERFORMED BY AN ARJO TECHNICIAN CONFIRMED MALFUNCTION OF THE PRINT CIRCUIT BOARD (PCB). WHEN THE ARJO TECHNICIAN OPENED THE BOX BEHIND THE PANEL, THERE WAS WATER INSIDE. THE ARJO TECHNICIAN COULD NOT DETERMINE EXACTLY WHERE THE WATER HAD GOTTEN INSIDE, AS THERE WERE NO CRACKS ON THE PANEL OR THE BOX COVER. BASED ON THE INFORMATION GATHERED, IT SEEMS LIKELY THAT THE WATER GOT UNDER THE PANEL OVERLAY AND CAME INTO CONTACT WITH THE ELECTRONICS INSIDE THE ASSEMBLY. THE CONTACT BETWEEN THE WATER AND THE ELECTRONICS COULD HAVE LED TO A SHORT CIRCUIT, RESULTING IN UNCOMMANDED MOVEMENT. HOWEVER, THIS HYPOTHESIS CANNOT BE CONFIRMED WITH CERTAINTY. IN SUMMARY, THE BATH WAS USED FOR A PATIENT HYGIENE AND IN THAT WAY IT PLAYED A ROLE IN THIS EVENT. THE BATHTUB WAS MOVING UPWARD UNCOMMENDED DUE TO THE DEVICE MALFUNCTION, SO THE DEVICE WAS NOT UP TO THE MANUFACTURER¿S SPECIFICATION. THE COMPLAINT WAS DECIDED TO BE REPORTED DUE TO UNCOMMANDED BATH MOVEMENT UPWARDS WHILE THE PATIENT WAS IN THE BATH, WHICH COULD HAVE CAUSED A DEVICE DESTABILIZATION AND PATIENT'S FALL OR ENTRAPMENT.
Description of Event or Problem
ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF SYSTEM 2000 BATH. IT WAS REPORTED THAT WHILE A PATIENT WAS SITTING INSIDE THE BATH, THE BATH STARTED TO RAISE UNINTENDED . THE CUSTOMER EMPHASIZED THAT THE CAREGIVERS DID NOT CHOOSE THE LIFTING FUNCTION. TWO SECONDS AFTER, THE BATH STOPPED. NO PATIENT INJURY WAS REPORTED.