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

Model Number AL14110-US

Device Problem Device Fell (4014)

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

Event Date 08/25/2022

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).Collection of additional information is ongoing.The conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Arjo has received a customer complaint regarding a parker bath, indicating that the parker door is falling down due to a gas strut failure.Based on the information gathered, the unit was being used in this condition.A facility employee (from the maintenance department) informed arjo of the defect.It was reported that the door did not want to rise.No injuries or health consequences were reported.

Manufacturer Narrative

Arjo received a customer complaint regarding a parker bath, indicating that the parker door is falling down due to a gas strut failure.Based on the information gathered, the unit was being used in this condition.A facility employee (from the maintenance department) informed arjo of the defect.It was reported that the door did not want to rise.No injuries or health consequences were reported.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.In the product labelling it is not only identified that should this be noticed the device should be repaired, it also instructs the user to look for the failure, and on top of that instructs the part to be replaced regularly.Following the information gathered, the claimed bathtub was under arjo service contract and device history of service repairs revealed that the gas strut was never replaced before.It had not been replaced since date of manufacturing (2011).The operating and product care instructions informs the device user that door gas strut is subjected to wear and should be replaced every 3rd year.The parker bath involved in the event was manufactured about 11 years before this malfunction occurred.Following the operating and product care instructions: ¿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, the root cause was found to be related to normal wear of the component which may be prevented by replacements in regular intervals and following the product checks.In summary, the device was not up to the manufacturer¿s specification due to faulty door part (gas strut).It is not known whether this bathtub was in use with the resident when the gas strut failed.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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15585426
• MDR Text Key: 307067472
• Report Number: 3007420694-2022-00153
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/13/2022

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 Model Number: AL14110-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2011
• 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