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

Model Number AL27010-EU

Device Problem Unintended System Motion (1430)

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

Event Date 07/25/2022

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).The parker bath inspection performed by an arjo representative after the event revealed that the door locking mechanism mounted within door was worn and no high force was required to open the door.Based on the history review of the device, the locking mechanism and the door handle had been replaced about two years before the event occurred.Nevertheless, the parker bath was not under arjo service contract.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.¿ following the information collected the parker bath door handle did not open by itself but the caregiver leaned on the door handle which contributed to the parker bath door opening.The ifu for parker bath includes detailed description concerns usage of the door handle in the bath: "the parker bath has a door handle that works as a door lock.The door handle needs to be aligned with the sticker showing an open or closed lock.To unlock the door: press the door handle down until aligned with the sticker showing an open lock.To lock the door: press the door handle up until the handle is aligned with the sticker showing a closed lock." the ifu provides the instructions how to use door together with the supporting pictures.Based on the investigation performed, two factors were taken into consideration: the door locking mechanism could not have been regularly checked on a weekly basis and a wear of the door locking mechanism could have caused the bathtub door to open easily when the caregiver leaned on the locking handle.In summary, according to the gathered information, the parker bath's door opened during patient¿s bathing, therefore from this perspective, the bathing system did not meet the performance specification.The bath was used for patient hygiene and in that way it played a role in this 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 bathing, and the failure was not detected prior to use.

Event Description

Arjo was notified of an event involving a parker bath.It was reported that while the patient was bathing, a caregiver leaned on the parker bath door handle and the parker bath door opened.The patient did not sustain any injuries.

• 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: 15272669
• MDR Text Key: 305262640
• Report Number: 3007420694-2022-00136
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 08/23/2022

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: AL27010-EU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2018
• 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