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

Model Number AZR23110-GB

Device Problem Device Tipped Over (2589)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo was notified about an event with involvement of malibu bathtub, where it was reported that device almost tipped over during use.After the bathtub was drained of water the caregiver was transferring the patient sitting on the chair out of the bathtub.When the chair was already out of the bath, the device started to tip over and the patient slid from the chair.The caregiver held the bath to stop it falling onto patient and called for assistance.When it came bathtub was put in an upright position.The involved patient did not sustain any injury.The caregiver had a sore back.According to provided information no treatment was applied to caregiver.

Manufacturer Narrative

On 2018-apr-18 arjo was notified about an event with the involvement of malibu bathtub, where it was reported that device almost tipped over during use.After the bathtub was drained of water, the caregiver (mother of the patient) was transferring the patient sitting on the bathtub chair.When the chair was lifted, out of the bath, the device started to tip over and the patient slid from the chair.The caregiver held the bath to stop it from falling onto patient and called for assistance.When it came, bathtub was put in an upright position.The involved patient did not sustain any injury.The caregiver had a sore back after the incident.According to provided information no treatment was applied to caregiver and she did not go to the hospital.The review of similar reportable events with the involvement of the malibu/sovereign bath in last years, revealed low number of similar events.During evaluation of the device, the arjo representative found that bathtub was not fixed to the ground and was not leveled properly.The leveling screws were just about out of the bath.In the bathroom where the involved tub was placed the floor heating was used.This bathtub was commissioned by arjo in 2009, but according to the information received from the customer facility representative the bathrooms were refurbished in 2015 and 2016, so probably it required to remove the bathtub.There was no record of this bathtub re-commissioning performed by arjo after the bathroom refurbishment.The customer facility did not request for the reinstallation procedure in accordance with the manual to be performed by an arjo representative.Before the refurbishment of facility bathrooms the service of involved tub was carried out in june 2015, while the first service after refurbishment was requested by customer facility and performed by arjo in february 2017.According to the reports of services performed after the refurbishment these inspections did not reveal lack of floor attachments or other related issues.This tub was under arjo service contract and the last maintenance of the device before the event was performed on 2018-feb-27.Based on the report of this service no malfunction was detected.According to operating and product care instructions [ifu; (b)(4) dated on april 2008] delivered with the involved device, the equipment must be installed by appropriately trained personnel according to the assembling and installation instructions [(b)(4) issued in april 2008 - active at the time this device was manufactured].This manual provides instructions regarding proper floor fixtures installation and includes the following information reminding the need to use floor attachments: "to prevent the bath tub from falling over, the floor fixtures provided in the installation kit have to be used when installing malibu/sovereign.The floor construction must be suitable for anchoring the bolts." (p.9) "when the work [installation] is completed check that: all details are mounted corresponding to the assembly instructions." (p.5) moreover, to confirm that malibu/sovereign bathtub is correctly installed after the bathtub is fixed to a building structure the load test should be performed on the transfer chair positioned outside of the tub.Following the installation manual the weight of the applied test load (according to the maximum lifting capacity of the lift arm) should be 195kg (430 lbs) maintained on the bath chair for a minimum of 20 minutes.The bathtub should also be levelled by tightening the foot nuts against the floor fixtures.After the reported issue, following the technical evaluation results and upon the agreement with the customer facility, this bathtub has been re-installed according to the manufacturer specification by the arjo representative and was put into service.At the time of the event the bath was not up to the manufacturer's specification.According to the collected information when the incident occurred bath was used for patient therapy.The complaint was decided to be reported based on the allegation that the bathtub almost tipped over and as this malfunction is likely to pose a resident or caregiver at risk.Corrected data: please note that field d.5 was updated according to the received information.

• Brand Name: MALIBU
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• MDR Report Key: 7510091
• MDR Text Key: 108154823
• Report Number: 3007420694-2018-00106
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: AZR23110-GB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2018
• Distributor Facility Aware Date: 04/18/2018
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2018
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 86