MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTROY; LIFT, PATIENT, AC-POWERED

Model Number GAB1011-01-GB

Device Problems Corroded (1131); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Pain (1994)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

• Brand Name: ENTROY
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 , SW; SW 24121, SW
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 , SW; SW 24121, SW
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 6916995
• MDR Text Key: 89489161
• Report Number: 3007420694-2017-00204
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: GAB1011-01-GB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2017
• Distributor Facility Aware Date: 09/05/2017
• Device Age: 14 YR
• Event Location: Other
• Date Report to Manufacturer: 10/05/2017
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 95