MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MALIBU; ILJ

Model Number AZL23115-GB

Device Problems Migration or Expulsion of Device (1395); Device Tipped Over (2589); Installation-Related Problem (2965)

Patient Problems Pain (1994); Injury (2348)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for malibu/sovereign we have been found low number of other similar cases.With the amount of sold devices and with comparison to the daily use of them the occurrence rate observed for complaints with this failure mode in last 5 years is considered to be increasing but very low.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of the specification - bath wasn't installed to the floor.The device was being used for patient handling and in that way contributed to the event.Product instruction for use (ifu) is provided with each device.Ifu (04.Az.00_11gb from october 2014) informs: "the equipment must be installed by appropriately trained personnel according to the assembly and installation instructions.Requirements in the assembly and installation instructions can only be superseded by local code." section "preparations" included in ifu informs also about: site preparations: "prior to installation of malibu/sovereign bath the floor and walls within the required area must be finished." "floor attachments: the floor construction must be suitable for anchoring the bolts." actions before the first use: "make sure that the bath has been installed according to the assembly and installation instructions." assembly and installation instructions (06.Az.00_6gb from october 2014) referred in ifu, informs about action after installation: "when the work is completed check that: all details are mounted corresponding to the assembly instructions.(.)" instructions provides also information about floor attachment: "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." it warns also: "always place the floor fixture on the head end of the bath tub, opposite from the lift arm." "two fasteners must be installed at each fixture or the bath might tip." the received information showed that involved malibu bath was installed after the delivery by the arjohuntleigh field service technician on (b)(4) 2015.Service report confirmed the installation and performed load test.Information provided with this complaints showed also that when the technician installed the bath he was assured "there was no under floor heating in the room but there was and he hit a pipe the contractors (b)(4) said not to worry as they would isolate the room and to go ahead and fix the bath which he did and commissioned, it may well be that (b)(4) have since removed the bath to access the heating" on 29th september 2015 we received information about an adverse event where tub tipped during use.[(b)(4) in question is an external company who provides services of medical and electrical engineering related to inter (b)(4): installation and maintenance].Device examination performed by the arjohuntleigh representative after the reported incident showed that a bath was not fixed to the floor despite installation performed in (b)(4).The alteration to bath's assembly is confirmed by missing fixing plates and empty holes drilled in the floor with raw plugs.On 06-oct-2015 we received information from (b)(4) regarding uninstallation of a bath: as per (b)(4): "i have been contacted by (b)(4), they have told me that the bath was moved by a third party but there isn't any evidence of who it was (either (b)(4) or another company).The brackets are also not available." please note that the involved bath is not under arjohuntleigh's service contract.From above findings we conclude that this incident was caused by user error: unauthorized modification of a device - uninstalled bath.Not fallowing recommendation included in instruction for use regarding device preparation.Installation error - bath wasn't installed after repairs, and should not be used with patients.The received information and our evaluation as described above are showing that if malibu's installation requirement were followed in accordance to instruction for use, there would be no patient or caregiver at risk.

Event Description

Initially it was reported by arjohuntleigh representative that malibu bath was tipping during use."bath was used, with one carer present.Bath seat was swung out over bath and the water was allowed to drain.After a short period, while water was draining, bath tipped over on to side, resulting in user, sliding off on to the floor from a height of approx.500mm" as a result of this incident the resident sustained (b)(6) on right elbow (15 mm) and leg stumps sore.Next day injured complained he had hit his head, resulting in headache.Applied treatment: paramedic attended.They called district nurse who attended to (b)(6) and treated existing pressure sore.

Manufacturer Narrative

(b)(4).On (b)(6) 2015 we received information from the facility's contractor about the resident's death however this information was not confirmed by the facility.We don't find resident's death to be related to this event as there was no indication made by the customer or any other parties that fall of the resident occurred over 6 weeks before additional information was provided could have caused or contribute to the resident's death.We decided to update the competent authorities about resident's outcomes, however this information doesn't effect to final conclusions already sent in previous report.

• Brand Name: MALIBU
• Type of Device: ILJ
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5146440
• MDR Text Key: 28144344
• Report Number: 3007420694-2015-00195
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Followup
• Report Date: 10/13/2015,09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: AZL23115-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2015
• Distributor Facility Aware Date: 09/29/2015
• Device Age: 11 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/13/2015
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 75