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Device Problems Use of Device Problem; Device Tipped Over; Detachment of Device or device Component
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.

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Brand NameENTROY
Manufacturer (Section D)
verkstadsvagen 5
eslov 2412 1
SW  24121
Manufacturer (Section G)
verkstadsvagen 5
eslov 2412 1
SW  24121
Manufacturer Contact
pamela wright
12625 wetmore
ste. 308
san antonio , TX 78247
MDR Report Key3832481
Report Number9611530-2014-00027
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type User facility,Company Representative
Remedial Action Notification
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/17/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator OTHER
Date Manufacturer Received03/18/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2012
Is The Device Single Use? No
Type of Device Usage Reuse