MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-29 for MALIBU manufactured by Arjohuntleigh Polska Sp. Z O.o..
[79033989]
(b)(4). An investigation was carried out into this complaint. On (b)(4) 2017 arjohuntleigh was notified about an incident with malibu bathing system. It was stated that the resident fell from the seat while the transfer chair was raising. Following information reported by the nursing staff, before the incident, while they have been attempting to attach the chair to the lifting arm, the chair catches failed to locked into the attachment mechanism of the lifting arm. As a consequence the connection between the transfer chair and lifting arm was unstable. There was no serious patient injury as a result of the fall. Malibu bath is intended for therapeutic bathing and showering of care adult residents, designed especially for hospitals, nursing homes and other health care uses. When reviewing reportable events for malibu device, we have found limited number of other cases where the chair was not securely attached to the lifting arm. We have been able to establish that there is no complaint trend concerning this kind of events. The device was inspected after the incident by arjohuntleigh representative. No fault nor deficiencies were noted, the device was working as intended. Product instruction for use (ifu 04. Az. 00/12 gb dated on january 2015), which is delivered with each device, includes information how to properly and safely use the device and secure transfer chair onto the lift arm. - before every use a user shall check that all parts are in place, there is no damage or missing parts. - "to avoid the patient from falling out of the device, make sure that all catches are in a locked position". Also, the graphic in ifu shows how to attach chair to the lifting arm. - "to avoid the patient from falling out of the device, make sure that all catches are in locked position". - "place the transfer chair to the attachment of the lift arm and hook up the transfer chair". The indication in the complaint was that the chair failed to locate into the attachment mechanism of the lift arm and was balancing on the "axis spindle". The arjohuntleigh technician who evaluated the bathing system, recommended that the customer should receive additional product training. The above would suggest that the most likely root cause of the issue is related to the user's techniques used while attaching the chair to the lifting arm. There was no product malfunction, safety catch mechanism worked as intended. It may be possible, that a caregiver did not ensure that the catch locked in place when the chair was placed in the lift. It could happen that the chair was attached to the lift with handle or part of a chair frame not design for this purpose. Please note that the chair has only one part, a pivot, that is used to secure the chair in the attachment (hook) of the lift arm. When a chair is placed in the hook, the chair weight lowers the catch, which then snap back into place locking the chair in the lift proving that the attachment is made correctly. In conclusion, although no technical failure of the bath was found during on-side inspection by arjohuntleigh representative, the device transfer chair was reported to be separated from the lifting arm and from that perspective, the bathing system did not meet its performance specification. It was used for patient's care and this way contributed to alleged event. Although there was no serious injury reported, due to the nature of this incident we are reporting this event to competent authorities due to the potential of harm with a high severity.
Patient Sequence No: 1, Text Type: N, H10
[79033990]
Arjohuntleigh was notified about an incident with malibu/sovereign on (b)(6) 2017. It was stated that the resident fall from the seat while it was raising. The nursing staff reported that when attempting to attach the chair to the lifting arm, the chair failed to locked into the attachment mechanism of the lift arm and was balancing on the "axis spindle". There was no serious injury reported, a resident sustained bruising to elbow and under arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00150 |
| MDR Report Key | 6676273 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-05-25 |
| Date Facility Aware | 2017-06-08 |
| Report Date | 2017-06-29 |
| Date Reported to FDA | 2017-06-29 |
| Date Reported to Mfgr | 2017-06-29 |
| Date Mfgr Received | 2017-06-08 |
| Device Manufacturer Date | 2016-10-19 |
| Date Added to Maude | 2017-06-29 |
| 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 | MS. KINGA STOLINSKA |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer Phone | 698282467 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052, PL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALIBU |
| Generic Name | BATH, SITZ, POWERED |
| Product Code | ILM |
| Date Received | 2017-06-29 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | UL. KS. WAWRZYNIAKA 2 KOMORNIKI, 62-052, P PL 62-052, PL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-29 |