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.

Manufacturer Narrative

The investigation is ongoing and further information will be provided upon conclusion of the investigation.

Manufacturer Narrative

According to the information gathered, an arjo service technician was injured while performing annual preventive maintenance of the system 2000 bathtub at the customer's site.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.The inner metal plate that goes along the bathtub is located inside the bath panel and is only accessible to service technicians while inspecting or repairing the device.Therefore, caregivers and patients do not have access to this component.The photographic evidence and information gathered in the course of this investigation were consulted with the technical department.It seems most likely that the sharp edges on the inner metal plate was a result of non-conform part delivered from the supplier.The edges of this part should be blunted after laser cutting.However, this component had sharp edges and no signs of any processing on this part can be seen.Arjo device failed to meet its performance specification since the edge of the metal part was sharp and not dulled.The device was not used for a patient treatment at the time of the event.The complaint was decided to be reportable due to serious injury reported.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 17001539
• MDR Text Key: 315916348
• Report Number: 3007420694-2023-00109
• 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: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2020
• 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): Required Intervention