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

Model Number AL24010-EU

Device Problems No Apparent Adverse Event (3189); Device Fell (4014)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

Arjo received a customer complaint for a parker bath.It was indicated that the parker bath's door was not staying up but was falling due to the failure of the gas strut.The customer continued to use the bath after being aware of the defect.No injuries or health consequences were reported by the facility.The faulty part (gas strut) was replaced.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Arjo received a customer complaint for a parker bath.It was indicated that the parker bath's door was not staying up but was falling due to the failure of the gas strut.The customer continued to use the bath after being aware of the defect.No injuries or health consequences were reported by the facility.An arjo technician visited the facility to repair the device.According to the arjo technician the gas strut was damaged as there was a piece of plastic that was broken off.The faulty part (gas strut) was replaced by an arjo representative.According to additional information received the bath door was falling slowly.The parker 500 bath door can be opened by pulling the lever down and lifting the door up.The gas spring mechanism is designed to make it easily open the door and keep the door balanced in the raised position to avoid dropping.A tube with a compression spring inside assists the gas strut when opening the door.Review of post-market surveillance data, information received from the arjo product engineer and additional simulations performed confirmed that in case of defective gas strut of the parker 500 bathtub, there is no risk that could result in the door falling freely.The parker 500 bathtub has 2 safety features in case of gas strut failure and door free falling: 1) the door opens to an obtuse angle, which means that its centre of gravity, which is positioned quite high, will cause the door to tilt outwards instead of aiming to close.2) presence of a tension spring which assists the gas strut when opening the door.The tension spring will always attempt to push the door upwards and due to this, the door will stop when falling (when the gas strut is not present or is damaged).The mechanism described above is also supported by the fixing screw, which must be tightened to the correct torque (to the maximum setting).If there is looseness on it, it is possible for the door to fall, but at a very low speed.The parker user manual (ifu; 04.Al.01_9) reminds the customer to check the operation of the door on a weekly basis to detect any faults related to this assembly.Unintentional closing of the door and lack of resistance are symptoms noticeable when checking the device.According to received information the gas strut required replacement as the piece of plastic in this component was broken off.The defective part was not available.Based on the very limited information received and the unknown circumstances of the gas strut malfunction, it was not possible to determine the exact cause of the failure.The device was not up to the manufacturer¿s specification due to faulty door part (gas strut).The device was used for treatment of the patient despite the defect of the part.Please note that this complaint was initially reported but information received during the course of the investigation showed that gas spring failure in parker 500 cannot lead to direct risk for a patient or a caregiver.The review of post-market surveillance data revealed that there have been no reports of death or serious injury being a result of this type of malfunction in parker 500.Based on the above findings and the negligible likelihood of the occurrence of an adverse event, this type of malfunction does not meet the criteria for reporting and will not be reported in the future.However, arjo will continue monitoring the complaints and report any events in which death and/or serious injury occurred that arjo device contributed to.

• Brand Name: PARKER BATH
• 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: 18745587
• MDR Text Key: 335847302
• Report Number: 3007420694-2024-00049
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AL24010-EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 01/25/2024; Not provided; Not provided
• Supplement Dates FDA Received: 03/21/2024; 04/19/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• 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