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

Model Number AP31211EU1011

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 04/27/2023

Event Type  Injury  

Event Description

Arjo was notified of an incident involving a system 2000 bathtub.According to information provided while performing annual preventive maintenance at the customer's site, an arjo service technician injured his forearm.He tried to remove the cartridge.The top of the cartridge popped out and, while attempting to remove it, the technician injured his forearm on the inner metal plate that goes along the bathtub.The injury required a suture on the forearm.

• 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: 17001538
• MDR Text Key: 315916462
• Report Number: 1419652-2023-00034
• Device Sequence Number: 1
• Product Code: ILJ
• UDI-Device Identifier: 05055982713566
• UDI-Public: (01)05055982713566(11)201116
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AP31211EU1011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2023
• Distributor Facility Aware Date: 04/27/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention