MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MALIBU/SOVEREIGN (INCL. DIGNITY); BATH, HYDRO-MASSAGE

Model Number AZL23110-GB

Device Problem Device Tipped Over (2589)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

The involved device was taken out of service and evaluated by the arjo representative.According to the results of inspection the bolts holding floor attachments were not loose, but the bath was able to back out of the rear attachment.Additional evaluation of the device required.The information collection and analysis is still on-going and further information will be provided in the next report.

Event Description

Arjo was notified about an event with involvement of (b)(6) bath.It was reported that the bath tipped over when the patient was in the hoist.The customer stated that floor attachments were loose.No injury was reported.

Manufacturer Narrative

Please note the 'date of event' has been amended as the one provided in the initial report was incorrect.Arjo was notified about an event with involvement of malibu bath.It was reported by the customer facility that the bath tipped over when the patient was transferred in the bath¿s integrated chair.The caregiver stopped the bath from further tipping and safely removed the patient from the chair.No injury was reported.Upon initial notification to arjo the customer stated that bath¿s floor attachments were loose.The involved device was taken out of service and evaluated by the qualified arjo representative.According to the results of inspection the bolts holding floor attachments were not loose, but the bath was able to back out of the rear floor bracket.Upon further checks it appeared that the fixing plates were installed in an incorrect position (reversed) that was not according to the installation requirements.The floor fixtures were re-installed according to the manufacturer¿s instructions and device have been placed back to use.This device in question was under the arjo service agreement.Malibu/sovereign equipment is intended for assisted bathing and showering of adult residents in care facilities or in home care environment.According to the malibu instructions for use (ifu; 04.Az.00_12 dated on january 2015 ¿ delivered with this device) the equipment must be installed by appropriately trained personnel according to the assembly and installation instructions (06.Az.00_6gb issued in october 2014).This manual provides instructions (together with supporting graphics) regarding correct installation of floor fixtures 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 must be used when installing malibu/sovereign.The floor construction must be suitable for anchoring the bolts.¿ ¿when the work is completed check that: all details are mounted corresponding to the assembly instructions.¿ please note that section ¿care and maintenance¿ of the ifu includes the caregiver obligations, inter alia the one related to the mechanical attachments such as floor fixtures to be checked on a weekly basis: ¿check mechanical attachments: check that all screws and nuts are tightened and that there are no gaps.¿ according to the information collected the bathtub was able to tip due to incorrectly installed floor bracket.Based on the performed analysis, it is likely the main cause of the event was incorrect installation of the floor attachments, which allowed the bath foot to move out from the required position.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 evaluation of the device, it was incorrectly installed and tipped, so was not according to the manufacturer¿s specification.This complaint was decided to be reported to the regulatory authorities in abundance of caution due to indication of malfunction, which may lead to the patient fall and result in an injury occurrence.

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 9595668
• MDR Text Key: 198518478
• Report Number: 3007420694-2020-00006
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AZL23110-GB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other