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

Model Number AL14111-US

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number 9611530.Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).The evaluation of the bathtub revealed that the door gas strut should be replaced.The device was repaired.Additional information will be provided in a follow-up report upon the investigation conclusion.

Event Description

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.According to the collected information the customer 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 a parker bath.During a service visit requested by the customer for another issue (a leaking tub drain), an arjo technician noticed that parker door bath was not staying up and was falling down fast.Following the arjo technician¿s statement, no visible damage of a gas strut was noticed.Based on the collected information the device might have been in use in this condition and the customer did not inform arjo about the issue before visit.No injury or health consequences were reported.The faulty parts (tub drain, two jets and door strut) were replaced.Before the bath was released for further use, it was tested and confirmed as operated correctly.The claimed bathtub was not under arjo maintenance and service contract.It is unknown how long the part which failed was used.The operating and product care instructions (opci; 04.Al.00) informs the device user that door gas strut is subjected to wear and should be replaced every 3rd year.It also provides warnings and actions that can be carried out to prevent situation reported from occurring: ¿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.¿ the claimed unit was manufactured about 14 years before this malfunction occurred.As per 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.¿ in summary, 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 competent 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: 10703388
• MDR Text Key: 212338362
• Report Number: 3007420694-2020-00164
• 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: 11/02/2020

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: No Information
• Device Model Number: AL14111-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other