MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z.O.O. MALIBU/SOVEREIGN (INCL. DIGNITY)

Model Number AZL23110-GB

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

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that the patient fell off the chair after the bath.The resident is "mobile and walks with sticks." she was having a bath, as she sat in the hoist chair she was lowered from the bath.When the chair was at its lowest position outside the bath and the caregiver replaced the hand set into the bath, the resident slipped off the chair together with the plastic seat onto the floor.She had not used the safety belt at any time as they felt she could support herself.As additionally stated in the event description: "she also uses bath oils in the bath which could have made the chair slippery." device condition has been described as good.Function test did not show any anomalies and it was not possible to re-create this event.

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).As of 2014 that number was deactivated due to the site no longer shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by (b)(4) complaint handling establishment.An investigation was carried out into this complaint.When reviewing similar reportable events for malibu/sovereign we have been found a low number of other similar cases where the resident fell off the chair.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 very low and acceptable.The device was inspected by an (b)(4) representative at the customer site and found to be working within its specification; no failure was found that could have contributed to the reported incident.The device was being used for patient handling and in that way contributed to the event.A drill-down analysis was conducted into this event.From it, we stated that the cause of this event is related to user error.The reported situation is likely to be related to 3 factors: safety belt was not applied; as stated by the customer the involved resident is "mobile" and was assessed for use a bath without safety belt.Seat detached from a frame - as indicated by the originator of this complaint: "the seat would stay connected to the frame during 'normal' use," therefore we don't find this hypothesis to be related.As stated by the customer, the involved resident "uses bath oils in the bath which could have made the chair slippery." from above information we find factors related to safety belt and slippery chair to be most relevant, these 2 issues are likely to be related to user error.Product instruction for use (ifu) is provided with each device.Ifu (04.Az.00_2gb from april 2008) informs about importance of resident assessment: "we recommend that facilities establish regular assessment routines.Caregivers must assess each resident according to the following criteria prior to use: the resident must be able to sit in an upright position, normally defined as active or semi-active.(.)" caregiver must always make sure that: "transfer chair seats etc.Are fastened and all screws tightened." it warns also: "never leave the resident unattended at any time due to risk of a fall or other dangerous situations." from above excerpts and the provided information we can state that this event is caused by incorrectly assessed resident what was communicated by the service technician to the customer: "advised they should use the safety belt when a patient is sat in the chair." above factors are in line with our risk analysis and show possible cause of this incident: resident drag herself out of the product and she had not used safety belt.Wrong mobility category in proportion to intended use, resident is sliding or slipping out of the product.In accordance to above information we can state that the event was caused by user error - user did not follow ifu and lack or poor training as no dates of last training to the caregiver were provided and details of trainings were not available for company representative.From the above evaluation we find the cause of this incident to be related to user error: incorrectly assessed resident for a use with malibu bath - safety belt should be applied for this resident.The caregiver did not pay attention during lifting the resident out of tub.Above factors were supported by slippery chair as the resident used oils in the bath.The received information and our evaluation as described above are showing that if malibu's warnings were followed in accordance to product documentation, there would be no patient or caregiver at risk.

Manufacturer Narrative

Add'l info will be provided following the conclusion of the investigation.Ref imp # 1419652-2015-00129.

Event Description

As a part of complaint handling process the feedback was provided to the customer regarding incident reported to us on (b)(6) 2015.On (b)(6) 2015, the response from the customer was sent who disagreed with investigation conclusions.After further communication with the customer, additional information was provided referring to some narrative of the reported incident that was not included during initial interview.This significant information that was not provided in initial report relates to the detachment of the seat from the seat frame additionally provided information showed that when the chair was at its lowest position outside the bath and the caregiver replaced the hand set into the bath, the resident was standing from the seat and during this he fell with the detached plastic seat onto the floor we are currently in contact with the customer to return seat back to confirm the reported malfunction and perform further investigation.

Manufacturer Narrative

A drill-down analysis was conducted into this event, however we were not able to find the exact cause of the reported event.The investigation conducted into this problem, concluded with the following: in transit it is very unlikely that you would slide of the chair since the malibu mk3 chair has handles that surrounds the resident and on the malibu mk4-5 the resident is meant to use a belt.Reported adverse events tend to occur with the chair in the lower position while getting on or off the chair.The received information for this complaint showed that the involved device was equipped with an old seat.Due to customer concerns, we asked the facility to return part (seat) for the further examination with an offer to replace a seat for a new one.However, despite sales and service unit's efforts, the customer did not agreed to replace seat, and no part was available for the return.The above evaluation shows that one of the possible root causes of this event appears to be user error.Product instruction for use (ifu) is provided with each device ifu (04.Az.00_2gb from april 2008) provides information about correct and safe use of the product.Instruction for use provides also information about procedure of transferring the resident.This warning concerns additional checking of seat during use.In relation to above evaluation there are 2 potential factors related to the cause of the reported event: it appears the seat may not have been sufficiently well attached to the chair's frame: related to the nature of the reported incident (detached when the resident was standing) and the customer's concerns, this can't be confirmed as no part was returned (despite our attempts) user error - seat not correctly attached to a chair's frame and not checked before the use.We would like to add that additionally received information (after providing feedback to the customer) showed that the seat slipped when the resident was standing from the chair, and did not detach fully.

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste. 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4707249
• MDR Text Key: 5723086
• Report Number: 3007420694-2015-00077
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AZL23110-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: 04/09/2015
• Distributor Facility Aware Date: 03/17/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/09/2015
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• 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: 94 YR
• Patient Weight: 47