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

Model Number AP31300GB1010

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that while a parent was bathing their child and when the shower was being used to 'rinse' the child they screamed and the water temperature was judged to be hot.The water temperature allegedly increased suddenly after 10 minutes of bathing the baby, the moment when mum used hose from the bath to wash baby's back.Red area of skin was noted at back of head, neck and upper back.Baby had cool water over area for period of time, no blistering and red skin resolved in 20-30 minutes.

Manufacturer Narrative

The bath was inspected by an arjo engineer and no fault was identified.The technician checked the water temperature from the bath inlet and it was 42 degree celsius and from the shower 40 degree celsius, which is the temperature within the system settings interval.The parent stated that the temperature was the same for bath and shower, which would be inline with the technicians' results of inspection.This system is equipped with the scalding protection which shuts off the water in less than 10 seconds when the system senses temperature of 45 degree celsius.Additionaly an audible and visual alarm is triggered.Apart from the system, the product instruction for use (ifu) warns to always check the water temperature with naked hand before directing the water on the patient.Ifu also states to "allow a few seconds for the water to reach the preset temperature" and "let the patient to feel the water by hand before directing the water stream on the patient".Additionally, the baby was washed by their parent.According to ifu: "this equipment is intended for therapeutic bathing and showering hospital or care facility residents under the supervisor of trained skilled nursing staff [.].All other users must be avoided." based on the above, the product functionality and results of technician inspection, it is deemed unlikely that the serious injury could occur from showering.Nothing indicates that the arjo product caused the alleged scalding.The root cause can be determined as user's misunderstanding on how to use the equipment.The system 2000 bath was used for a baby 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.This complaint was decided to be reported to the competent authorities taking into accout the nature of the complaint and to be transparent in the approach.The water temperature raised suddenly during bathing, which allegedly resulted in an injury to a child.Following this investigation it is deemed unlikely that the serious injury could occur with this scenario.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17727967
• MDR Text Key: 323157052
• Report Number: 3007420694-2023-00217
• Device Sequence Number: 1
• Product Code: ILJ
• UDI-Device Identifier: 05055982713917
• UDI-Public: (01)05055982713917(11)200316
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/12/2023

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 Number: AP31300GB1010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• 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): Other
• Patient Age: 18 MO