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

Model Number AZL23110-GB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjo was notified about an incident with involvement of malibu bathtub.According to the available event description the caregiver was using the chair function of the bath to turn the resident.The caregiver turned to empty bath and while this was being done the resident fell off the chair.The resident sustained a laceration to her eyebrow and a black eye.The resident was taken to hospital.Two paper stitches were applied to head wound.

Manufacturer Narrative

The arjo representative was notified about an incident with the involvement of malibu/sovereign bathtub, where it was reported that resident fell off the bath transfer chair.Based on the information provided by the customer facility representative, the incident happened when the bath chair was raised to take the resident out of the bathtub.Later, the caregiver turned to drain the water from the bathtub and while doing this, the resident fell off the chair.Based on additional information received, the resident fell out of the chair towards the floor whilst reaching for her walking frame.Due to fall the resident sustained a laceration to her eyebrow and a black eye.She was taken to hospital where two paper stitches were applied to the resident's head wound.The review of similar reportable events with the involvement of the malibu bath in last 5 years, revealed a low number of similar events.The arjo representative visited the facility to perform a device evaluation and interview.According to the inspection results no malfunction was detected.The bathtub was found to be in good condition (expected for the age of the device) - the chair safety belt and other functions of the bathtub were checked and their correct functioning was confirmed.The bath was also secured to the floor with fixtures at the time of event.Therefore the bathtub was up to the manufacturer's specification.Based on the received information the involved caregiver was trained of the device usage in january 2017.The arjo representative was also informed that at the time of event the internal customer facility care procedure required 1 caregiver per bath, but after the incident it was changed to 2 caregivers required for each bathing.This malibu bathtub is intended for therapeutic bathing and showering of care adult residents under the supervision of trained caregivers with adequate knowledge of the care environment, its common practices and procedures, and in accordance with the guidelines in the operating and product care instructions (ifu).According to the event description the resident was left without direct supervision when the caregiver was emptying the bathtub after therapy.This let the resident to try to reach the walking frame and attempt to exit from the transfer chair on her own.Therefore this event might be considered as result of not following the ifu warnings - leaving the resident unattended.In summary, the device was up to manufacturer's specification after the event occurrence as no malfunction was indicated during evaluation.The bath was used for patient hygiene and in that way it played a role in this event.This complaint was reported due to the resident fall which could result in serious injury upon reoccurrence.

• Brand Name: MALIBU/SOVEREIGN
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• MDR Report Key: 7547589
• MDR Text Key: 109362056
• Report Number: 3007420694-2018-00115
• 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: 06/20/2018

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 Caregivers
• Device Model Number: AZL23110-GB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2018
• Distributor Facility Aware Date: 05/14/2018
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/20/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/28/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 104