MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-05-23 for MALIBU AZR23110-GB manufactured by Arjohuntleigh Polska Sp. Z O.o..
[45707009]
(b)(4). Additional information will be provided following the conclusion of the investigation. An investigation was carried out into this complaint. When reviewing similar reportable events for malibu we have found other similar cases where chair detached from the lifting arm. We have been able to establish that there is no complaint trend concerning these kinds of events. Nursing staff manually transferred the chair from the malibu bath on the ground floor and reattached it to the malibu bath on the third floor. The chair detached from the lift arm- and caught the nurses arm causing bruising. The device was being used by the caregiver and in that way contributed to the event, unfortunately there is no information if there was any patient involved due to fact that event occurred a year ago (date of event - (b)(6) 2015). Also there is no possibility to confirm if the device was according to its specification due to fact that it was not checked by technicians (arjohuntleigh has been aware of incident one year later). However we can state that the device failed to work as intended when the event occurred. There are limited information provided to complaint. Despite our best efforts to obtain details of this event, we were informed that the facility will not provide more information. All devices are equipped with instructions for use which clearly inform how to safety use the device. Ifu for malibu contain wording: "always make sure that the transfer chair is safely attached to the wheel chassis (i. E. That the spring loaded catch has clicked into its locked position). " "when using the lift arm with transfer chair and/or using the height adjustable bath tub, the operator must assure that there are no obstructions or persons in the immediate vicinity that could impede its movement. " the ifu contains also preventive maintenance section which inform that caregiver should preformed periodic testing of the device. Every week: visually check mechanical attachments: check that all screws and nuts are tightened and that there are no gaps. Check safety catch and transfer chair attachment for ease of movement and intact parts. Perform functionality test. Visually check all exposed parts. The chair is attached to the lift arm and secured by the locking mechanism. There are 3 main factors that can lead to detachment of a seat: a) lifting mechanism was faulty and not allowing to seat to be correctly attached to the lifting arm. B) there was an obstruction near the seat and while lowering, seat hit an obstacle and was pushed upward, this possibility is supported by not correctly functioning locking mechanism. C) seat wasn't correctly attached to the lifting mechanism by the user. Due to limited information provided with a complaint we are unable to determine what exactly happened in the facility. We could not confirm if there was any product malfunction or the seat was attached to lifting arm correctly. Please note, that if caregiver would have followed every guideline given in instruction for use (including checking seat connection), there would be no user at risk.
Patient Sequence No: 1, Text Type: N, H10
[45707010]
Initially it was reported to arjohuntleigh representative that: " back in (b)(6) 2015 one of the nursing staff manually transferred the chair from the malibu bath on the ground floor and reattached it to the malibu bath on the third floor. The chair detached from the lift arm on the bath on the 3rd floor and caught the nurses arm causing bruising as it fell".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2016-00093 |
| MDR Report Key | 5672964 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-05-23 |
| Date of Report | 2016-04-26 |
| Date Facility Aware | 2016-04-26 |
| Report Date | 2016-05-23 |
| Date Reported to FDA | 2016-05-23 |
| Date Reported to Mfgr | 2016-05-23 |
| Date Mfgr Received | 2016-04-26 |
| Device Manufacturer Date | 2011-01-11 |
| Date Added to Maude | 2016-05-23 |
| 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 | MRS PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE, STE 308 |
| Manufacturer City | SAN ANTONIO, TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALIBU |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-05-23 |
| Model Number | AZR23110-GB |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 5 YR |
| 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, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-23 |