MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CLASSIC LINE 2; BATH, HYDRO-MASSAGE

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/31/2023

Event Type  Death  

Event Description

Arjo was informed about the event with the participation of the maxi sky 2 ceiling lift and classic line 2 bath.After lowering the patient to the bath, the patient was left unattended.The patient who was mentally and physically disabled person drowned in the bathtub.No malfunction of arjo devices that could contributed to this event was currently identified.This report is related to involved classic line 2 bath.The report for maxi sky 2 is submitted under importer reference number: 1419652-2023-00057.

• Brand Name: CLASSIC LINE 2
• 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: 18100691
• MDR Text Key: 327719934
• Report Number: 1419652-2023-00058
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2023
• Distributor Facility Aware Date: 10/31/2023
• Date Report to Manufacturer: 11/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 25 YR
• Patient Sex: Male