MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-05 for ENTROY GAB1011-01-GB manufactured by Arjo Hospital Equipment Ab.
[89489161]
(b)(4). Investigation has been completed and the conclusions are following. Arjohuntleigh was informed about the incident with entroy pool lift. It was reported that a female resident ((b)(6)) was being transferred from a wheelchair on to the entroy chair with chassis, the moment she sat on the chair it suddenly collapsed dropping the resident to the floor. In a result a resident felt pain in the leg. No medical intervention nor hospitalization was required. Inspection of the device conducted by the arjohuntleigh representatives found out signs of the rust on the metal components. The box section of the chair that is attached to the transporter or pool lift mast was broken off, causing the chair detachment. When reviewing reportable complaints for entroy pool lift, we have not found other similar complaints, thus this incident has been deemed a single occurrence. This equipment is intended for lifting and transporting residents to and from a bathroom in a care facility and to assist with the bathing process. The entroy is an equipment used in a pool environment where chlorine and hydrochloric acid in various ratios with water is used. This in combination with ambient temperature constitutes the environment where corrosion may occur. Corrosion is the deterioration of a metal as a result of chemical reactions between it and the surrounding environment. All metal structures can corrode. To limit the process of corrosion on metal components user manual (04. Ga. 05_4gb) indicates to rinse the equipment with water and dry each part of the entroy chair with a clean cloth every day. Once in a year an arjohuntleigh authorized service shall check all vital parts for corrosion. The last service was performed by arjohuntleigh technician in july 2017. A technician followed the guidance provided in technical service guides. The hoist was examined, fully functional test and load test was performed. The device met the required manufacturer's specifications. A technician recommended to the customer to replace batteries, also both arm supports as coating cracked and rust was detected. This particular device was in use for over 14 years when the incident occurred. Therefore, taking into account the environment in which the device resided and the device age it can be stated that the corrosion occurred as a natural process due to normal wear of the equipment. No other complaints were recorded, since the device was delivered to the customer, until the event took place. To sum up, the device was being used for patient care and thus played a role in the incident. It failed to meet its performance specification as the chair detached and a resident fell to the floor. Although there was no a serious injury sustained we report this incident in abundance of caution as if this situation were to recur it may result in harm of high severity. We are going to monitor the similar nature of complaints and if this would arise, initiate an appropriate action.
Patient Sequence No: 1, Text Type: N, H10
[89489162]
Arjohuntleigh was informed about the incident with entroy pool lift. It was reported that a female resident ((b)(6)) was being transferred from wheelchair on to the entroy chair with chassis, the moment she sat on the chair it suddenly collapsed dropping the resident to the floor. In a result a resident felt pain in the leg. No serious injury has been sustained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00204 |
| MDR Report Key | 6916995 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-05 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-09-04 |
| Date Facility Aware | 2017-09-05 |
| Report Date | 2017-10-05 |
| Date Reported to FDA | 2017-10-05 |
| Date Reported to Mfgr | 2017-10-05 |
| Date Mfgr Received | 2017-09-05 |
| Device Manufacturer Date | 2003-02-24 |
| Date Added to Maude | 2017-10-05 |
| 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 | 2017-10-05 |
| Model Number | GAB1011-01-GB |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 14 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 | 2017-10-05 |