MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AP01000-EU

Device Problem Fracture (1260)

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number (b)(4).Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).Collection of additional information is ongoing.The conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Arjo received a customer complaint for a system 2000 bath where it was indicated that the arjo clean diluted disinfectant sprayed into the caregiver¿s eye due to damaged disinfection handle.The caregiver's eye was flushed with saline and the caregiver went to the emergency room because the eye was still stinging.The eye was flushed again and the caregiver was discharged without treatment with diagnosis of irritation.

Manufacturer Narrative

Arjo received a customer complaint for a system 2000 bath where it was indicated that the arjo clean disinfectant was sprayed into the caregiver¿s eye due to damaged disinfection handle.The caregiver's eye was flushed with saline and the caregiver went to the emergency room because the eye was still stinging.The eye was flushed again and the caregiver was discharged without treatment with a diagnosis of irritation.Based on the information received the involved bath had been inspected by an arjo representative one week before the event occurred.No issues had been found at that time.Therefore, it seems that the yellow disinfection handle was damaged between the last inspection of the device and the date of the event.However, the circumstances of this remained unknown.The customer ordered a new shower handle and the part was delivered to the customer on 19 -dec-2022.The system 2000 bath instruction for use (ifu) informs the user about the following actions which must be performed when specified to ensure that the product remains within its original manufacturing specification.According to the system 2000 bath instructions for use (ifu): "every week: examine the bath for cracks or other damage.Check for leakage" nevertheless, it should be underlined that the only situation of not wearing protective equipment - glasses - might contribute to the scenario where disinfectant could spray into someone's eyes.It was confirmed that the involved caregiver was not wearing protective equipment when the event occurred.The system 2000 bath ifu warns: "warning: always use protective gloves and protective eye wear when dealing with concentrated disinfectant.Avoid getting it on your skin or in your eyes.If contact occurs, rinse with copious amount of water.If skin or eyes become irritated, consult a physician." from our evaluation, it can be concluded that the event was a result of product labeling not being followed - the user was not wearing personal protective equipment at the time of the event.In summary, the device was not up to the manufacturer¿s specification during the event occurrence ¿ the disinfection handle was damaged.The bathtub was not used for patient hygiene at the time of the event, but it was prepared for use and in that way, it played a role in this event.This complaint was decided to be reportable due to splashing the disinfectant solution towards the caregivers' eyes which in combination with not using protective equipment, resulted in the injury.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16012622
• MDR Text Key: 308373887
• Report Number: 3007420694-2022-00208
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 01/11/2023

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: AP01000-EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2006
• 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