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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SYSTEM 2000; BATH, HYDRO-MASSAGE
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ARJOHUNTLEIGH POLSKA SP. Z O.O. SYSTEM 2000; BATH, HYDRO-MASSAGE Back to Search Results
Model Number AR55311GB11100
Device Problem Temperature Problem (3022)
Patient Problems Burn(s) (1757); Insufficient Information (4580)
Event Date 07/14/2021
Event Type  Injury  
Manufacturer Narrative
The device was evaluated by the arjo technician.According to the results of inspection, the scalding protection was working correctly and was shutting down the mixer when the cold water was isolated.The shower's water temperature display was flashing while the water temperature was stabilising after turn on.No malfunction related to the issue was detected.The investigation is on-going and further information will be provided in the next report.
 
Event Description
Arjo was notified about an incident with involvement of system 2000 bath.It was reported that the patient did have a red mark on her leg caused by the shower water having a spike in temperature when first turned on.
 
Manufacturer Narrative
Arjo was notified about an incident with involvement of system 2000 bath.It was reported that the patient did have a red mark on her leg caused by the shower water having a spike in temperature when first turned on.The device was evaluated by the arjo technician.According to the results of inspection, the scalding protection was working correctly and was shutting down the mixer when the cold water was isolated.The shower's water temperature display was flashing while the water temperature was stabilising after turn on.No malfunction related to the issue was detected.The system 2000 instructions for use (ifu (b)(4)) provides information important for correct and safe usage of the bathtub: ¿to prevent scalding, always check water temperature with your naked hand before directing the water on the patient.Do not use the gloves as it may insulate to the extent the water temperature can be misjudged.Point the flow of the water away from the patient.¿ the relevant information is also included in the ¿shower patient¿ section of the ifu: ¿ direct the shower handle away from patient.Press the trigger on the shower handle and direct the water stream away from patient.Place your naked hand in the water stream and make sure the water temperature is not too hot or too cold.(¿) p300: the display shows the temperature value.Allow a few seconds for the water to reach the preset temperature.Check the temperature setting on the display ¿ in summary, the system 2000 bath was used for patient hygiene, when the event occurred and therefore was involved in the incident.Based on the results of the technical evaluation, the device was functioning according to the manufacturer¿s specification, but as per customer allegation a water was too hot, so the device was not performing as intended during the event.This complaint was decided to be reported in the abundance of caution due to indication of a malfunction which resulted in a non-serious injury.
 
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Brand Name
SYSTEM 2000
Type of Device
BATH, HYDRO-MASSAGE
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks. piotra wawrzyniaka 2
komorniki PL-62 052
PL  PL-62052
MDR Report Key12266008
MDR Text Key264711961
Report Number3007420694-2021-00109
Device Sequence Number1
Product Code ILJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberAR55311GB11100
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/19/2021
Initial Date FDA Received08/03/2021
Supplement Dates Manufacturer Received07/19/2021
Supplement Dates FDA Received08/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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