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

Model Number AL21010-EU

Device Problem Device Fell (4014)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

Arjo received a customer complaint for parker bath.During service visit at the customer site an arjo representative noticed that a parker bath's door was not staying up but was falling due to the failure of the gas strut.The circumstances of the malfunction are unknown.No patient involvement and no injuries or health consequences were reported by the facility.

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

Manufacturer Narrative

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

Manufacturer Narrative

Arjo received a customer complaint for parker bath.During service visit at the customer site an arjo representative noticed that a parker bath's door was not staying up but was falling due to the failure of the gas strut.The circumstances of the malfunction occurrence are unknown.The facility did not indicate that the defective bath was not used with the patient.No injuries or health consequences were reported by the facility.The faulty part (gas strut) was replaced.The parker 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.If either gas strut or compression spring is defect the door will not stay in position up.This gradual deterioration will be noticeable in daily use.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.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.In summary, the device was not up to the manufacturer¿s specification due to faulty door part (gas strut).This complaint was decided to be reported to the regulatory authorities due to gas strut malfunction leading to bath¿s door falling and because the circumstances of the failure occurence are unknown.The facility did not indicate that the defective bath was not used with the patient.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17239576
• MDR Text Key: 318311099
• Report Number: 3007420694-2023-00158
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 08/25/2023

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 Model Number: AL21010-EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 06/12/2023; 06/12/2023
• Supplement Dates FDA Received: 07/27/2023; 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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