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 2017-07-26 for ENTROY GAB1000-01-GB manufactured by Arjo Hospital Equipment Ab.
[81595983]
(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 arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted. This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a use error the device did not perform as intended. An investigation was carried out into this complaint. A customer reported that two weeks ago (around (b)(6) 2017) a person (age (b)(6), described as of "slight built') fell from a chair hoist. As a result a resident sustained a laceration to the right side of the head and went to the local hospital to the emergency room as a precaution. No surgical intervention was needed and the patient was released the same day. The incident happened when a resident was being moved into the changing room after session in the pool. The detachable chair became detach and fell to the floor, ended up on top of the patient. The device which was involved in the incident was identified as entroy pool lift, model gab1000-01-gb with serial number (b)(4) what give us information that this device was produced and tested by (b)(4) in (b)(4) (now closed) in october 2008. At the time of event it was over 8. 5 years old. This pool lift was used with chair model gab1011-01-gb and serial number (b)(4), produced in (b)(4) in october 2008. Entroy is a pool lift system that consists of mast, which is floor-mounted, a transferable seat or stretcher, battery-powered lifting arm and waterproof handset. An entroy chair or stretcher fits on a chassis for patient transport and connects to the pool lift using the secure quick coupling system. The entroy system has been developed to offer a complete transport and transfer solution for all stages of the hydrotherapy cycle. Entroy is intended for disabled persons who need to transfer in and out of a therapy pool/swimming pool under supervision of skilled and trained personnel in accordance with the instructions in our manual. When reviewing similar reportable events for entroy we have found a low number of other similar cases where seat or stretcher detached from entroy's lifting arm or a base. There is very low complaint ratio for this kinds of events in last 5 years. Please note that to release the quick coupling and detach chair, the docking handle should be pulled out, and to lock the chair in place, the docking handle should be pressed in. A chair is properly paired with a chassis when a light indicator shows green. The equipment inspection performed by both a customer and an arjohuntleigh representative did not reveal any fault within the system. Entroy was functioning as intended. This would suggest that the docking handle and quick coupling was functional and able to lock the chair onto chassis without an issue. A customer, who inspected the system after the incident pointed out a few possible causes of chair detachment from chassis: - incorrect positioning of patient in the hoist chair, - hoist chair kept too high when moving from pool side to changing and hitting the door stopper just outside the changing room, - chair not correctly docked when hoisting out. Cares themselves were unable to point out the reason for the fall. The evaluation did not reveal any damage to the hoist, therefore second cause listed by the customer can be excluded, also incorrect positioning may result in patient fall however the chair if properly paired would remain in place, therefore this cause as a potential root cause can be excluded as well. It is worth mentioning, that under capa there were identified the following reasons for chair detachment: - the chair may become detached when a caregiver does not recognize that the chair has not be paired correctly, - when maintenance check was performed incorrectly and - wear on the docking connection causes the pin to hit the edges of the pairing cylinder instead of entering it. All of them were defined as use error. Since no fault was found within a device and the last maintenance was performed by arjohuntleigh representative a week before the incident, the cause related to incorrect maintenance can be excluded as a potential cause. Therefore, from the above, it can be concluded that the only plausible root cause of the event is related to incorrect docking chair into the chassis. Product's instruction for use (ifu), which is provided with each device (operating and product care instructions 04. Ga. 05/ 6gb from september 2005 for entroy and 04. Ga. 06/2gb from january 2003 for entroy chair with chassis) inform that user shall always make sure that: "the entroy chair and the entroy stretcher are properly docked onto the pool lift or a chassis", that the patient is sitting in the middle of the seat. When a patient is transported from pool lift to chassis, one of the steps described in ifu refer to proper docking the chair to the hoist (chassis). In order to do so the handle needs to be pulled "as soon as the tap has reached docking hole", further the document instructs to "keep the hand in this position until the chair/stretcher has landed correctly on the docking tap", "continue to lower the pool lift arm about 50 mm and press the handle in fully so that the indicator is totally green. Check that the docking tap has engaged fully in the docking hole". "warning! Never continue to lower the arm and leave the docking hole if the indicator is red or partly red. " from that, it can be stated that if entroy warnings and transferring procedures were followed in accordance to instruction for use and, there would be no patient or caregiver at risk. Taking into consideration the customer assumption, root cause identified under capa, ifu content and that there was no fault found within a system, it can be concluded that a root cause of the issue is related to use error - failure to recognize proper docking. In conclusion, there was not product failure, however it failed to meet its performance specification as a chair detached from the chassis resulting in patient fall. No serious medical consequences to health were reported as an outcome. The system was used for patient care at the time of event and was directly involved with the reported incident.
Patient Sequence No: 1, Text Type: N, H10
[81595984]
A customer reported that two weeks ago (around (b)(6) 2017) a person (age (b)(6), described as of "slight built') fell from a chair hoist. As a result a resident sustained a laceration to the right side of the head and went to the local hospital to the emergency room as a precaution. No surgical intervention was needed and the patient was released the same day. The incident happened when a resident was being moved into the changing room after session in the pool. The detachable chair become detach and fell to the floor, ended up on top of the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00164 |
| MDR Report Key | 6743299 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-07-26 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-06-13 |
| Date Facility Aware | 2017-06-27 |
| Report Date | 2017-07-26 |
| Date Reported to FDA | 2017-07-26 |
| Date Reported to Mfgr | 2017-07-26 |
| Date Mfgr Received | 2017-06-27 |
| Device Manufacturer Date | 2008-10-09 |
| Date Added to Maude | 2017-07-26 |
| 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 G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121, SW |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121, SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTROY |
| Generic Name | LIFT, PATIENT, AC-POWERED |
| Product Code | FNG |
| Date Received | 2017-07-26 |
| Model Number | GAB1000-01-GB |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121, SW SW 24121, SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-26 |