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

Model Number AL11501-GB

Device Problems Mechanical Problem (1384); Device Fell (4014)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided within the next report.

Event Description

It was reported by the customer facility that parker bath door keeps slamming shut due to the door gas strut fault.No injury occurrence was indicated.

Manufacturer Narrative

It was reported by the customer facility that parker bath door keeps slamming shut due to the door gas strut fault.No injury occurrence was indicated.The customer facility did not provide further information regarding circumstances of failure occurrence.Arjo representative recommended to the customer not to use the bath until is repaired.The device was inspected by the arjo qualified personnel member.It was found that the bottom mounting point of the gas strut had worn out and would no longer securely screw in to its housing.This caused the strut to separate off its mounting point.The part was replaced with a new one.The part was disposed right after the repair and no photographic documentation was available.The bathtub in question was under the service agreement and regular maintenance services were carried out by arjo.The service history was available and has been reviewed.On 2018-oct-17 the gas strut failed as the bottom mounting point had worn out and would no longer securely screw in to its housing.This caused the strut to separate off its mounting point.On 2018-oct-22 the arjo representative replaced the damaged gas strut.Despite our best efforts to obtain further details regarding the faulty part, it was not possible as no pictures were available and part was disposed after the repair.Please note that according to operating and product care instructions (ifu; (b)(4) dated on november 2005) delivered with the device, each user of the arjo equipment should follow the instructions from the booklet.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." the ifu also provides user with proper door usage instructions that should be followed to avoid malfunction and event occurrence: "never recline the bath unless the door is in the closed position" "always fit leg rest on opposite side of bath to door.If hung on the door - damage to the door will occur." the ifu also reminds the customer to check operation of the door regularly on a weekly basis to detect any failure related to this assembly.Based on the performed investigation it is not possible to establish the exact root cause of the claimed failure as the faulty part was not available for further evaluation.In summary, according to the customer allegation, the door gas strut failed and led to door falling.It is unknown if the bathtub was used for a patient hygiene at the time of event.Based on the collected information about the malfunction the device was not up to the manufacturer's specification.This complaint was decided to be reported to the competent authorities in abundance of caution due to the information about malfunction (door falling), which could have led to the injury occurrence and lack of information indicating circumstances in which the malfunction was detected.

• 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: 8072918
• MDR Text Key: 127871845
• Report Number: 3007420694-2018-00217
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AL11501-GB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2018
• Distributor Facility Aware Date: 10/17/2018
• Device Age: 13 YR
• Event Location: Home
• Date Report to Manufacturer: 12/14/2018
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other