SYSTEM 2000
Received Jan 2, 2025 · Event occurred Dec 1, 2023
Report 3007420694-2025-00005 · MDR key 21053542
Device
Product problems
- Use of Device Problem
- Insufficient Device Problem Information
- Use of Device Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Respiratory Arrest
- Insufficient Information
- Respiratory Arrest
- Insufficient Information
Narrative
Description of Event or Problem
ARJO WAS NOTIFIED OF AN EVENT INVOLVING SYSTEM 2000 BATH. ARJO SALES REPRESENTATIVES WAS INFORMED OF A PATIENT'S DEATH IN A SYSTEM 2000 BATHTUB. THIS OCCURRED OVER A YEAR AGO. THE CAREGIVER HAD LEFT THE PATIENT (A KID) ALONE TO GO GET CLOTHES AND THE KID HAD PROBABLY DROWNED.
Additional Manufacturer Narrative
PROCESS OF COLLECTING AND ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.
Additional Manufacturer Narrative
ARJO WAS NOTIFIED OF AN EVENT INVOLVING A SYSTEM 2000 BATH. ARJO SALES REPRESENTATIVE WAS INFORMED OF A PATIENT'S DEATH IN THE SYSTEM 2000 BATHTUB. THIS OCCURRED OVER A YEAR AGO (IN 2023). IT WAS INDICATED THAT THE CAREGIVER HAD LEFT THE PATIENT ALONE TO GO GET CLOTHES AND THE PATIENT HAD DROWNED WHILST THE CAREGIVER WAS GONE. THE INFORMATION COLLECTED DID NOT REVEAL ANY CORRELATION BETWEEN THE REPORTED PATIENT DEATH AND THE ARJO BATH INVOLVED IN THE EVENT. THERE WAS NO ALLEGATION OF ARJO PRODUCT MALFUNCTION. THE PERSON WHO REPORTED THE INCIDENT DIDN¿T PROVIDE DETAILED INFORMATION AS THE EVENT OCCURRED OVER A YEAR AGO (IN 2023). IN THE REPORTED EVENT, THE PATIENT WAS LEFT UNATTENDED, WHICH IS INCONSISTENT WITH THE SYSTEM 2000 INSTRUCTIONS FOR USE. THE SYSTEM 2000 BATH IFU (04.AR.12_22) STATES THE FOLLOWING; "WARNING: TO AVOID INJURY, MAKE SURE THAT THE PATIENT IS NOT LEFT UNATTENDED AT ANY TIME." IT IS ALSO UNKNOWN IF THE PATIENT WAS PLACED IN THE BATH ON THE LIFT, WHICH SHALL BE USED AS A SYSTEM WITH AN APPROPRIATE TRANSFER DEVICE. ACCORDING TO THE INFORMATION INCLUDED IN THE IFU: "COMPLETELY BEDRIDDEN PATIENT/RESIDENTS CAN USE THE BATHTUB. CORRECT TRANSFER EQUIPMENT SHALL BE USED." "THE BATHING MUST BE ASSISTED BY APPROPRIATELY TRAINED CAREGIVERS WITH AN ADEQUATE KNOWLEDGE OF THE CARE ENVIRONMENT AND ITS COMMON PRACTICE AND PROCEDURE, AND IN ACCORDANCE WITH THE GUIDELINES IN THE INSTRUCTION FOR USE (IFU). TRANSFER TO THE BATHTUB SHALL TAKE PLACE BY MEANS OF AN APPROPRIATE TRANSFER DEVICE." TO SUM UP, THE SYSTEM 2000 BATH WAS USED WITH THE PATIENT WHEN THE EVENT OCCURRED. CURRENTLY, ARJO IS NOT AWARE OF ANY DEVICE MALFUNCTION THAT COULD CONTRIBUTE TO THE EVENT. TAKING A CONSERVATIVE APPROACH, THIS COMPLAINT WAS REPORTED FOLLOWING AN INDICATION OF DEATH WHILE USING ARJO BATH.