MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTORY; FNG

Model Number GAB1000-01-EU

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab (under registration # (b)(4)).As of 2014 that number was de activated 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 ab's complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

Initially it was reported by arjohuntleigh representative that the resident fell from a chair during use."old man fell, chair lift were not properly secured, both chair and lift flipped, care taker gave alarm directly, ambulance came after 20 min.The assistant was with man, wrapped him in towels, caretaker and assistant talked with him all the time, he bleed from the ear, since it hit the floor.The man is paralyzed in his left side, arm and leg and wheelchair user and did therefore not feel any pain".Device examination showed that chassis sleeve had marks indicating that the docking has not been done properly.Marks were on the ball in the chair undercarriage.Overall condition of a device was good.As per a service technician: "it seems as if this is a user error, since the docking handle was dragged too early without checking that the equipment is aligned correctly".

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.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 decreasing and very low complaint trend for these kinds of events in last 5 years.The device was inspected by an arjohuntleigh representative at the customer site and found to be to the specification - no fault was found that caused or contributed to the event.All damages found with a device was described as related to the reported detachment.The device was being used for patient handling and in that way contributed to the event.Product's instruction for use (ifu) is provided with each device.(b)(4).Ifu informs that user must always make sure that: "the entroy chair and the entroy stretcher are properly docked onto the pool lift or a chassis." the device examination showed that no malfunction was found that caused or contributed to the reported event.The detailed device's assessment made by the service technician showed that there are damages that were most likely caused by the reported detachment of a seat and related to incorrect docking of a seat.Please note that product's ;operating and product care instructions' informs about correct docking of a seat: "to prevent unintentional release of the chair, a docking handle is fitted on the back of the transfer mechanism.This should be pulled out to release the quick coupling and pressed in when locking it.An indicator window shows green or red colour" instructions include also correct docking procedure of a seat: " place the pool lift arm in the correct position over the area intended for transfer.Lower the pool lift arm until the docking tap is at a height just below the docking hole of the entroy chair /entroy stretcher.Position the chair chassis/ stretcher chassis in front of the pool lift.It is very important that the arrows are pointing transversely to each other so that the chair/stretcher including chassis is positioned in a 90° angle in relation to the lift arm.Slowly raise the pool lift arm.Check that the docking tap meets the docking hole in the chair/stretcher properly.Put one foot on the chassis to stabilize.Pull the handle.Raise the pool lift arm slowly and release/push the handle after raising about 50 mm.Check that the docking tap has engaged fully in the docking hole.Note! normally the chassis will leave the floor for maximum 50 mm before the quick coupling releases.This will cause a small bump.Check that the indicator on the handle is totally green before the raising is continued.Warning! never raise the pool lift arm if the indicator is red or partly red.If the chassis will be lifted off the floor it can cause injury if it disconnects and falls down.Move away the entroy chair/stretcher chassis." please note that the possibility of incorrect docking was indicated by the service technician based on the damages of the equipment: "it seems as if this is a user error, since the docking handle was dragged too early without checking that the equipment is aligned correctly." from above we can conclude that this problem was caused by user error - user didn't followed warnings regarding correct docking and preserving patient's safety.The received information and our evaluation as described above are showing that if entroy's warnings and transferring procedures were followed in accordance to instruction for use and, there would be no patient or caregiver at risk.

• Brand Name: ENTORY
• Type of Device: FNG
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5254040
• MDR Text Key: 32281545
• Report Number: 3007420694-2015-00210
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/15/2015,11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: GAB1000-01-EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2015
• Distributor Facility Aware Date: 11/04/2015
• Device Age: 11 YR
• Event Location: Other
• Date Report to Manufacturer: 11/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2004
• 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): Hospitalization
• Patient Age: 70 YR