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

Model Number AL11510-GB

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was evaluated by the arjo representative.According to the results of inspection, a gas strut was found disconnected on door mechanism.The part was reinstalled and device confirmed to function correctly.The investigation is on-going and further information will be provided in the next report.

Event Description

Arjo has been notified about the incident with involvement of parker bath.The customer facility has initially requested for service of the device as the door hinge appeared to be broken, because the door was not staying up and was falling down.On (b)(6) 2020 upon further contact with the customer facility, arjo has been notified that an incident occurred.It was reported that during use, while the caregiver was removing a resident from the bath, the door fell on a caregiver¿s shoulder.The caregiver was bruised, no hospitalization was required.At the time of service visit at the customer facility the arjo representatvie was not informed about this incident.

Manufacturer Narrative

Arjo was notified about an incident with involvement of parker bath.The customer facility initially requested for service of the device as the door hinge appeared to be broken, because the door was not staying up and was falling down.On 2020-jul-29 upon further contact with the customer facility, arjo has been notified that an incident occurred.It was reported that during use, while the caregiver was removing a resident from the bath, the door fell on a caregiver¿s shoulder.The caregiver was bruised, no hospitalization was required.The device was evaluated by the arjo representative.According to the results of inspection, a gas strut was found disconnected on door mechanism.The part was reinstalled and device confirmed to function correctly.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 labeling it is not only identified that should this be noticed and the device should be repaired, it even instructs the user to look for the failure, and on top of that, instructs the part to be replaced regularly.Please note that according to operating and product care instructions (opci; 04.Al.00_4 dated on april 2007) delivered with the device, each user of the arjo equipment should follow the instructions from the booklet.In section ¿care and maintenance¿ the device user is informed that door gas strut should be replaced every 3rd year.According to the performed review of device service history no evidence of gas strut replacement was found, so the part was in use for unknown period of time before it failed.The claimed bathtub was under the arjo annual service contract and last service including preventive maintenance was conducted in november 2019.It should be underlined that the involved device was past its expected lifetime as per opci: ¿the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in this manual.¿ in connection with the subject of this investigation, the following warnings were included to prevent from any injury occurrence (page 5): ¿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 customer allegation, the door gas strut failed and led to door fall on the caregiver¿s arm during use with a patient.The device was not up to the manufacturer¿s specification due to faulty door part and in that way contributed to the event¿s occurrence.This complaint was decided to be reported to the regulatory authorities due indication of a malfunction, which led to no door support and an injury occurrence, when the door closed unintended.

Manufacturer Narrative

Arjo was notified about an incident with involvement of parker bath.The customer facility initially requested for service of the device as the door hinge appeared to be broken, because the door was not staying up and was falling down.On (b)(6) 2020 upon further contact with the customer facility, arjo has been notified that an incident occurred.It was reported that during use, while the caregiver was removing a resident from the bath, the door fell on a caregiver¿s shoulder.The caregiver was bruised, no hospitalization was required.The device was evaluated by the arjo representative.According to the results of inspection, a gas strut was found disconnected on door mechanism.The part was reinstalled and device confirmed to function correctly.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 and the device should be repaired, it even instructs the user to look for the failure, and on top of that, instructs the part to be replaced regularly.Please note that according to operating and product care instructions (opci; 04.Al.00_4 dated on april 2007) each user of the arjo equipment should follow the instructions from the booklet.In section ¿care and maintenance¿ the device user is informed that door gas strut should be replaced every 3rd year.According to the additional service history provided for the involved device, the door gas strut for this bathtub was replaced in (b)(6) 2016.It means that the part which failed in the investigated complaint was used for approximately 3 years and 8 months.The claimed bathtub was under the arjo annual service contract and last service including preventive maintenance was conducted in (b)(6) 2019.It should be underlined that the involved device was past its expected lifetime as per opci: ¿the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in this manual.¿ in connection with the subject of this investigation, the following warnings were included 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 customer allegation, the door gas strut failed and led to door fall on the caregiver¿s arm during use with a patient.The device was not up to the manufacturer¿s specification due to faulty door part and in that way contributed to the event¿s occurrence.This complaint was decided to be reported to the regulatory authorities due indication of a malfunction, which led to no door support and an injury occurrence, when the door closed unintended.This update of the report was performed according to an additional information regarding the device's service history including the time of last part's replacement received on (b)(6) 2020.

• 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: 10349092
• MDR Text Key: 207182111
• Report Number: 3007420694-2020-00130
• 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,Followup
• Report Date: 10/23/2020

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: AL11510-GB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 09/24/2020
• Supplement Dates FDA Received: 08/26/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other