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

Model Number GAB1011-01-GB

Device Problems Corroded (1131); Crack (1135); Unstable (1667); Device Tipped Over (2589)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

It was reported to arjo representative that there was an incident involving entroy pool lift.It was reported that during patient's transfer entroy chair tilted over to one side.According to information provided after cracking sound has been heard by the caregiver, chair has been immediately lowered and patient then safely removed.The resident did not sustain any injury.

Manufacturer Narrative

The faulty seat is awaiting to be replaced and following that it will be inspected further in order to determine the nature of the occurred malfunction.The investigation is still on-going and additional information will be provided in the next report.

Manufacturer Narrative

Arjo was notified about an event with involvement of the entroy pool lift.It was reported that during the patient's transfer entroy seat tilted to one side (the device¿s chassis was stable).According to the information provided, the cracking sound has been heard by the caregiver.The chair has been immediately lowered and patient then safely removed.The resident did not sustain any injury.The involved device was taken out of service and evaluated by the arjo representative.It was stated by the customer that the cracking sound came from the seat that is covered by the polyurethane layer.According to the visual inspection performed, the seat in question had two spots on the damaged pur layer, which were covered with glue by the customer facility.The faulty chair was replaced and taken for further inspection.The polyurethane foam layer was removed from the place where the seat was bent (upper part, near to the lifting pillar) and revealed rusted and cracked frame.According to the collected information, during the service performed by the arjo representative in may 2019 the customer was informed that the polyurethane foam is damaged.The customer was notified that this assembly should be replaced, but the quote to repair was not accepted at that time.Upon further use of the device the damage was progressing and led to frame crack, which occurred in october 2019.The seat unit is made of a material (polyurethane or pur) that feels warm to touch and is gently sprung at those edges that support patient¿s leg.Based on the provided information the entroy¿s seat frame was damaged, which caused its tilting when the patient was sitting on it.Therefore, the replacement was required.Please note that entroy operating and product care instructions (opci; 04.Ga.06_2 dated on january 2003 ¿ active at the time this device was manufactured) includes section related to maintenance that should be followed by the device user.It is stated in the opci that: ¿customer obligations shall be carried out by qualified personnel following the instructions in this manual.If something looks wrong with the product or deviates from normal function, contact immediately your local arjo service for support.¿ the customer is instructed in the opci guidelines also about the weekly maintenance obligations together with supporting illustrations, such as: ¿examine the entroy chair for damage.(¿)¿ ¿visual check of mechanical attachments by placing a foot on the chassis and pull the seat upwards with both hands.No gaps are allowed¿ the claimed device was manufactured in 2003, so over 16 years before this incident was reported.The useful life of this equipment, unless otherwise stated, is ten (10) years, subject to preventive maintenance being carried out in accordance with the instructions for care and maintenance.Based on the performed investigation, the root cause of this incident is considered to be related to use error as the device was utilized despite the visible signs of malfunction.In summary, according to the gathered information the entroy hygiene chair was used for patient handling at the time of the event and in that way contributed to the event.Based on the performed evaluation of the device seat was damaged.The complaint was decided to be reported to regulatory authorities in abundance of caution due to indication of device¿s seat tilt, which according to the allegation could have resulted in the patient¿s fall.

Manufacturer Narrative

The faulty seat has not been replaced to date and further evaluation in order to determine the nature of the occurred malfunction has not been conducted yet.The investigation is still on-going and additional information will be provided in the next report.

• Brand Name: ENTROY
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• MDR Report Key: 9384519
• MDR Text Key: 198511760
• Report Number: 3007420694-2019-00209
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2020

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
• Device Model Number: GAB1011-01-GB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 10/30/2019; 10/30/2019; 10/30/2019
• Supplement Dates FDA Received: 12/27/2019; 01/24/2020; 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other