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

Model Number AL25111-GB

Device Problem Unintended System Motion (1430)

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

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number (b)(4).Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).According to an inspection of the parker bath conducted by an arjo representative, the square door lock drive was worn, resulting in the lever slipping in the housing.This defect caused the door to open on its own.The defective part was replaced.The investigation is ongoing and further information will be provided in the next report.

Event Description

Arjo was notified of an event involving a parker bath.It was reported that while the patient was bathing, the handle mechanism malfunctioned and the parker door opened fully, flooding the floor.The tub was in the reclining position.The patient did not sustain any injuries.

Manufacturer Narrative

Arjo was notified of an event involving a parker bath.It was reported that while the patient was bathing, the handle mechanism malfunctioned and the parker tub door opened fully, flooding the floor.The tub was in the reclining position.The patient did not sustain any injuries.The parker bath inspection performed by an arjo representative after the event revealed that the door locking mechanism mounted within door failed.He indicated that the door lock mechanism was worn, resulting in the lever slipping in the housing.This defect caused the door to open on its own.The arjo representative replaced the defective part.According to arjo representative, the bath in question was used approximately 10 times a day.The parker bath was under arjo service contract.The last maintenance of this bath was conducted by arjo on 14-apr-2022 (one month before the reported event) and did not revealed any door lock mechanism failure.Also, the last annual service conducted by arjo on 07-sep-2021 did not revealed any issues with door lock mechanism.The service history was checked for this device and no door lock mechanism replacement was found.The parker bath is subject to wear and tear, and some actions must be performed when specified to ensure that the product remains within its original manufacturing specification.To avoid malfunction resulting in injury, the user should make sure to conduct regular inspections and follow the recommended maintenance schedule provided within the parker instructions for use (ifu).Actions before every use: "if any part is missing or damaged - do not use the product".In section ¿care and preventive maintenance¿ in the ifu the preventive maintenance schedule is available, which includes the obligation to check door on a weekly basis: ¿open and close the door and check its supports for correct function i.E the door should not drop by itself during closing.Check the lock for proper function.¿ based on the collected information, it can be concluded that the cause of the door lock mechanism failure could be related to the normal wear of the part.The functionality of the bathtub was checked a month before the event and no problems were found, the bath was working properly at the time.Based on the information received from the customer, it is concluded that the door opened by itself while the patient was bathing, which may suggest that the part failed due to wear and tear.In summary, according to the gathered information, the door lock mechanism failed during patient¿s bathing, therefore the device was involved in the reported event.The device was not up to the manufacturer¿s specification at the time of the event.This complaint was decided to be reported to the competent authority in abundance of caution due to the unintentional opening of the bath door while the patient was 's bathing, and the failure was not detected prior to use.

• 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: 14615957
• MDR Text Key: 302579427
• Report Number: 3007420694-2022-00089
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/29/2022

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: AL25111-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2019
• 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