MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2015-11-30 for ENTORY GAB1000-01-EU manufactured by Arjo Hospital Equipment Ab.
[32281545]
(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.
Patient Sequence No: 1, Text Type: N, H10
[32281546]
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".
Patient Sequence No: 1, Text Type: D, B5
[34107124]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00210 |
| MDR Report Key | 5254040 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2015-11-30 |
| Date of Report | 2015-11-04 |
| Date of Event | 2015-10-26 |
| Date Facility Aware | 2015-11-04 |
| Report Date | 2015-12-15 |
| Date Reported to FDA | 2015-12-15 |
| Date Reported to Mfgr | 2015-11-30 |
| Device Manufacturer Date | 2004-12-13 |
| Date Added to Maude | 2015-11-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE, STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTORY |
| Generic Name | FNG |
| Product Code | FNG |
| Date Received | 2015-11-30 |
| Model Number | GAB1000-01-EU |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-11-30 |