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

Model Number AL27010-EU

Device Problem Leak/Splash (1354)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the results of the device inspection, the bah frame had damage around the latch mechanism.It is possible that the bath latch was not fully engaged during use.The tilt actuator allowed the bath to tilt further with resident in it due to play in the tilt motor.The bath was working correctly apart from these issues.The investigation is ongoing and further information will be provided in the next report.

Event Description

Arjo has been notified about an event related to parker bath.It was reported by the customer facility that one of their clients had slipped on a puddle of water that had formed after using the bath and fell.The resident sustained bruising to the hands and knees which were not present the next day.No treatment was used.

Manufacturer Narrative

Arjo has been notified about an event related to parker bath.It was reported by the customer facility that one of their clients had slipped on a puddle of water that had formed under the bath after use and fell to the floor.The resident sustained bruising to the hands and knees which were not present the next day.No treatment was used.The device was taken out of use and evaluated by the qualified arjo representative.According to the results of the device inspection, the bath frame had damages around the latch mechanism.It was possible that the bath latch was not fully engaged during the event.Moreover, the tilt actuator allowed the bath to tilt further with a resident in it due to play in the tilt motor.The bath was working correctly apart from these issues.Arjo does not have a service agreement for the bathtub in question.In line with the information received from the customer facility representative, no service of the involved device has been carried out within the last 12 months preceding the event.According to the performed technical evaluation, the most probable scenario is that the bath had been overfilled, which together with not fully closed door (due to damaged frame around the latch) and extended tilting range could have caused water to leak through the gap between the door and bath shell.This would create a puddle of water that is likely to be visible for the caregiver operating the device.If so, upon detection of the malfunction and water on the floor the device should be removed from service.However, as per the received information the device was used despite the customer being aware of the leakage, which resulted in the occurrence of the investigated event.The parker is subject to wear and tear, and the care and maintenance actions must be performed when specified to ensure that the product remains within its original manufacturing specification.Parker bath instructions for use (04.Al.01_6 dated on june 2012, active at the time device was manufactured) informs user about the importance of regular maintenance: ¿to avoid malfunction resulting in injury, make sure to conduct regular inspections and follow the recommended maintenance schedule.¿ ¿to avoid injury and/or unsafe product, the maintenance activities must be carried out at the correct frequency by qualified personnel using correct tools, parts and knowledge of procedure.Qualified personnel must have documented training in maintenance of this device.¿ according to ifu parker has to be serviced according to the care and preventive maintenance schedule, which also includes maintenance performed yearly.The ifu informs caregiver about obligations and actions to be performed regularly e.G.: ¿weekly (¿) check door/seal: open and close the door and check its supports for correct function i.E the door should not drop by itself during closing.Check the lock for proper function.¿ as per ifu if the problem cannot be solved with the problem-solving actions (troubleshooting section), it is recommended to contact an arjo for a solution.Based on the collected information and conducted analysis the most probable root cause of the occurred event is related to user error ¿ especially not following ifu guidelines regarding usage and maintenance of the device.In summary, according to the gathered information the involved bath was used for patient handling at the time of the event.Based on the performed technical evaluation, the device was leaking, so it was not according to the manufacturer¿s specification.This complaint was decided to be reported due to regulatory authorities due to an indication of a device malfunction and the resident fall, which could have resulted in a serious injury occurrence.

• 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: 9719821
• MDR Text Key: 198754808
• Report Number: 3007420694-2020-00031
• 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: 03/18/2020

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: AL27010-EU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 70