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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/04/2019

Event Type  Death  

Event Description

Arjo was notified about the event with involvement of system 2000 bath.It was reported that a patient died during use of the bathtub.According to the received information the care unit has requested a training.No further information was made available to date.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 9213187
• MDR Text Key: 162984519
• Report Number: 1419652-2019-00203
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2019

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: No Information
• Device Model Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2019
• Distributor Facility Aware Date: 10/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death