MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTROY

Device Problems Use of Device Problem (1670); Device Tipped Over (2589); Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848); Swelling (2091)

Event Type  malfunction  

Event Description

Ref importer report: (b)(4).

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.Trend concerning above reportable events is very low and decreasing.Please note that arjohuntleigh manufactured about (b)(4) entroys to date.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of specification, but only on pats that we do not see as contributing to the event or outcome.The device was being used for patient handling and in that way contributed to the event.From the information received injury occurred to the patient: swelling forehead, bruise on knee and redness on inner elbow.The product instruction for use (ifu 04.Ga.05/6gb from september 2006) is attached to each device and includes warnings and safety instructions important for safe and correct use of the product.Instruction for use include the following warning: "the entroy chair and the entroy stretcher are properly docked onto the pool lift or a chassis." instructions for use also provides instructions of the correct and safe transferring the patient.Instructions for use inform also that the docking tap must be wiped dry before use.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 color.We have not been able to find any contributing manufacturing anomalies.From our findings as stated above we can conclude that this problem was caused by user error - the user didn't follow warnings regarding correct docking and preserving the patient's safety.This was confirmed and documented during our inspection of the customer site.The received information and our evaluation are showing that if the entroy labeling's warnings and transfer procedures were followed there would be no patient or caregiver at risk.

• Brand Name: ENTROY
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste. 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3832481
• MDR Text Key: 4503444
• Report Number: 9611530-2014-00027
• 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: User Facility,Company Representative
• Remedial Action: Notification
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1