MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-10 for MALIBU/SOVEREIGN (INCL. DIGNITY) AZL23110-GB manufactured by Arjohuntleigh Polska Sp. Z.o.o..
[5723086]
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.
Patient Sequence No: 1, Text Type: D, B5
[13240169]
(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.
Patient Sequence No: 1, Text Type: N, H10
[56212314]
Add'l info will be provided following the conclusion of the investigation. Ref imp # 1419652-2015-00129.
Patient Sequence No: 1, Text Type: N, H10
[56212316]
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.
Patient Sequence No: 1, Text Type: D, B5
[57613854]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00077 |
| MDR Report Key | 4707249 |
| Report Source | 06,07 |
| Date Received | 2015-04-10 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-02-18 |
| Date Facility Aware | 2015-03-17 |
| Date Reported to FDA | 2015-04-09 |
| Date Reported to Mfgr | 2015-04-09 |
| Date Mfgr Received | 2015-03-17 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2015-06-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE STE. 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2102787040 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z.O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI PL-62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | PL-62052 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALIBU/SOVEREIGN (INCL. DIGNITY) |
| Product Code | ILM |
| Date Received | 2015-04-10 |
| Model Number | AZL23110-GB |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 7 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z.O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI PL-62052 PL PL-62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-10 |