MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AP31300EU1010

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 12/17/2022

Event Type  Injury  

Event Description

Arjo was notified of an event involving a system 2000 bath.It was reported to arjo that the patient allegedly suffered burns while showering.Following the information received, the patient was showering without nursing staff (alone) using a hygiene chair next to the system 2000 bath and was using a shower handle from the bathtub.It was indicated the patient received a second-degree burn on the right forearm (about 5cm) and a first-degree burn on the left forearm.When nurses heard noises (from throwing the shower handle and from the patient) they attended to the patient and found him with burns.The patient was taken to the hospital the next day for treatment of the wounds.In the initial communication from the customer, it was indicated that the patient could also have burnt himself with hot water from a water cooker.

Manufacturer Narrative

As per the results of technical inspection performed by an arjo representative no malfunction was found within the device.The arjo representative measured the maximum water temperature outlet from hand shower (42,2°c) and tub inlet (41,7°c) with external temperature logger.No anomalies were detected.Moreover, the device was responding correctly by activation of scalding protection when the water temperature was over the calibration¿s limit.Based on the above, we were not able to confirm the customer allegation that the water temperature raise significantly to cause such burns as reported.The system 2000 instructions for use (ifu; 04.Ar.12_5) 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 resident.Do not use gloves as it may insulate to the extent the water temperature can be misjudged.Point the flow of the water away from the resident.¿ "to avoid injury, ensure that the resident is not left unattended at any time." based on the performed investigation, it was not possible to determine the exact cause of the event.No malfunction of the device was found.Additionally, based on the initial information received from the customer, other sources of burns cannot be ruled out either.Following the product ifu the water temperature should be controlled to prevent accidental scalding and the resident should not be left unattended.In summary, the system 2000 bath was used for the resident 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 the water temperature raised significantly, so the device was not performing as intended during the event.This complaint was decided to be reported to competent authorities due to indication of a malfunction which resulted in a serious injury.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16291221
• MDR Text Key: 308713785
• Report Number: 3007420694-2023-00022
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: AT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AP31300EU1010
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention