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

Model Number AP32211US0010

Device Problem Device Tipped Over (2589)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo was notified of an incident involving a system 2000 bath.It was indicated that the system 2000 bath was lowered to its lowest point.The tub was half-filled with water.A patient entered the tub and sat in the bason without the use of any support equipment.The bathtub then shifted, at which point the caregiver heard a loud bump.The bathtub touched the floor, and a crack appeared on top of the bathtub.No injuries were indicated.A maintenance worker from the facility removed the back cover from the bathtub and found that the screw on the side corresponding to the crack was loose.The maintenance worker tightened the screw, estimating that the screw was sticking out about half an inch and was not tightened.

Manufacturer Narrative

Arjo was notified of an event involving a system 2000 bath.It was indicated that the bath was lowered to the lowest point and was half-filled with water.A patient entered the bathtub without use of any support equipment.The bathtub then tipped, at which point the caregiver heard a loud bump.The bathtub touched the floor, and a crack appeared on top of the bathtub.The patient did not sustain any injury as a consequence.A maintenance worker from the facility removed the back cover from the bathtub and found that one of the screws holding the bathtub with the bath¿s main panel was loose.This malfunction was detected next to the point where the crack in the bathtub gel-coat appeared.The maintenance worker tightened the screw estimating that the screw was sticking out about half an inch and was not tightened.The system 2000 baths are equipped with two screws which connect the bathtub to the main panel of the bath.The inspection of the involved system 2000 bath performed by an arjo representative revealed that the device was in good condition aside from the crack in the bathtub.The arjo representative was not able to verify the loose screw as this screw had been tightened before the arjo representative visit at the customer site.The system 2000 bath involved in this event was under arjo service contract and the last maintenance was performed about 2 months before the event.No issues with screws were found during the last maintenance.The service history of the device was also checked and there was no records regarding loose screws connecting the bathtub to the main bath panel.Loose screws are a visible defect.In such a case, the bathtub would not be in a horizontal position, but would be tilted or lowered.The device user should act according to the guidelines included in the instructions for use (ifu; 04.Ar.12): ¿actions before every use: check that all parts are in place.Check bath and accessories for damage.If any part is missing or damaged - do not use the product." following the information received from the facility, it was also indicated that the patient was entered the tub without use of any support equipment.According to the ifu: "active and semi-active patient/residents (i.E.Able to sit upright self-supported on the side of a bed or toilet) and completely bedridden patient/residents can use the bathtub.Correct transfer equipment shall be used." ¿alenti, calypso and combilift are the recommended arjohuntleigh lift hygiene chairs that can be used with the system 2000 bath.¿ based on the investigation performed, it was not possible to determine the exact root cause of the event.According to the information received, it can be hypothesized that the bathtub tipped due to a screw that had become loose over time, and in addition, an external force might have affected the integrity of the bathtub, since the bathtub was used without a lift hygiene chair.This could also have contributed to the weakening of the bathtub's gel-coat and its damage.In summary, the system 2000 tub was being used with a patient and therefore played a role in the event.The device failed to meet its specifications at the time of the event.This complaint was decided to be reported to the competent authorities due to risk of an injury occurrence related to bath tipping during use.

• 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: 16511580
• MDR Text Key: 311571750
• Report Number: 3007420694-2023-00048
• Device Sequence Number: 1
• Product Code: ILJ
• UDI-Device Identifier: 05055982716475
• UDI-Public: (01)05055982716475(11)190415
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AP32211US0010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2019
• 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): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 88 KG