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.

• 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 Key: 16291328
• MDR Text Key: 308713899
• Report Number: 1419652-2023-00008
• 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: Distributor
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2023
• Distributor Facility Aware Date: 01/10/2023
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention