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

Model Number AL14111-CA

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The evaluation of the bathtub revealed that the door gas strut was damaged (slightly oval) and should be replaced.The device was removed from use until repaired.The investigation is on-going and further information will be provided in the next report.

Event Description

Arjo was informed about the malfunction of the parker bath.The customer facility requested for service of the device and upon inspection on-site the arjo representative noticed that the door was falling very quickly to closed position if not held.According to the collected information the device was used in this condition and did not inform arjo about the issue before visit.No injury or health consequences were reported.

Manufacturer Narrative

Arjo was informed about a malfunction of the parker bath and was requested for service of the device.Upon inspection on-site the arjo representative noticed that the door was falling very quickly to closed position if not held.According to the collected information the device was used in this condition and the customer did not inform arjo about the issue before visit.No injury or health consequences were reported.The evaluation of the bathtub revealed that the door gas strut was worn and damaged (slightly oval).The device was removed from use until repaired.Parker bath is intended for assisted bathing and showering of adult residents in care facilities.It is equipped with a full-length side opening for easy access of mobile patients.The 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.List of recommended steps can be found in product preventive maintenance schedule (pm0684_01 dated on december 2002) active at the time when this device was manufactured and delivered with it.The preventive maintenance schedule reminds the customer to check operation of the door regularly on a weekly basis to detect any failure related to this assembly: ¿open and close the door and check the lock and supporting gas strut for correct and smooth operation.¿ it informs also that the door strut should be replaced after 48 months/4 years of functioning.Please note that operating and daily maintenance instructions (odmi, 04.Al.00/1 dated on june 2003) delivered with the device, includes information which should be followed by each user of the arjo equipment.In connection with the subject of this investigation, the following warnings were established to prevent from any injury occurrence: ¿always ensure that the equipment is handled by trained staff.¿ ¿always ensure that the bathers limbs are clear of the door before closing.¿ ¿always keep fingers clear of the door when closing.¿ in summary, according to the collected information, the door gas strut was worn.The device was not up to the manufacturer¿s specification due to faulty door part, which was noticed upon the service of the device.This complaint was decided to be reported to the regulatory authorities in abundance of caution due to gas strut malfunction leading to bath¿s door falling and because the device was most probably 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
• MDR Report Key: 10354904
• MDR Text Key: 207182309
• Report Number: 3007420694-2020-00131
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

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: AL14111-CA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other