MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH; BATH, HYDRO-MASSAGE

Model Number 420*

Device Problem Device Fell (4014)

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

Event Type  malfunction  

Event Description

During preventive maintenance visit at the customer site an arjo service technician noticed that a parker bath's door was not staying up but was falling due to the failure of the gas strut.Based on the collected information the device had been in use in this condition before the issue was detected.The customer did not inform arjo about the issue before the visit.No injury or health consequences were reported.

Manufacturer Narrative

The parker (420) bath's door can be opened by pulling the lever down and lifting the door up.The gas spring is adjusted to facilitate door opening and to keep the balance of the door in raised position, to avoid door falling.A gas strut is a hydraulic pump that is a chamber filled with oil and air that is compressed by a rod pushing a piston into the chamber.The movement of these parts is sealed off by hydraulic seals.After time these seals will leak air and oil and the functioning of the pump will gradually deteriorate, up to a point when the weight of the door will no longer be fully supported by the strut.This gradual deterioration will be noticed in daily use.The equipment is subject to wear and tear, and recommended maintenance instructions must be performed when specified to ensure that the equipment remains within its original manufacturing specification.The parker bath involved in the event was manufactured over 21 years before this malfunction occurred.Following the operating and daily maintenance instructions (pm0607 rev.2): ¿the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in this manual.¿ based on the performed analysis and information received in the course of this investigation, it seems that the root cause might be related to normal wear of the component.At the time of event the device did not meet manufacturer specification due to worn door gas strut.It was unknown if the bathtub was used for patient hygiene.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 device was not removed from service, but used in this condition.

• Brand Name: PARKER BATH
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18197987
• MDR Text Key: 329207058
• Report Number: 3007420694-2023-00280
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/23/2023

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 Operator: Other
• Device Model Number: 420*
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2002
• 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