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| Model Number AL27110-EU |
| Device Problem
Unintended Movement (3026)
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| Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was evaluated by the arjo qualified representative.According to the results of inspection, the door lock mechanism was loose in such a way that the door lock lever has a double angle of up and down movement.If the lever was moved upwards, it was scraping off the protrusion on the door.Another problem is in the pin of the door, the door moves on the pin even when the pin is supported by a stop.The customer requested to exchange the whole device.The investigation is on-going and conclusion is not yet available.Additional information will be provided within the next report.
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Event Description
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It was reported that during use the bath's door lock disengaged, the door flipped out and made a mark on the wall.The customer stated that at the closing of the bathtub by the handle, there are symbols of "locked" and "unlocked" door.The handle always remained within these symbols.However, at this time the customer notice that the handle did not stop at the "locked" symbol, but was going further.Neither patient involvement nor injury occurrence were indicated.
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Manufacturer Narrative
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The investigation is on-going and conclusion is not yet available.Additional information will be provided within the next report.
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Manufacturer Narrative
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Arjo requested the customer facility for return of the bathtub in order to perform further evaluation.We are waiting for confirmation from the customer that the bathtub is available.The investigation is on-going and conclusion is not yet available.Additional information will be provided within the next report.
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Manufacturer Narrative
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It was initially reported that during use the bath's door lock disengaged, the door unlocked unintended, then flipped out and made a mark on the wall.The customer stated that at the closing of the bathtub's door, by the handle there are symbols of "locked" and "unlocked" door.The handle always remained within these symbols.However, at this time the customer noticed that the handle did not stop at the "locked" symbol, but was going further.No injury occurrence was reported as a consequence of this event.The device was removed from usage and arjo qualified representative performed inspection.According to the results of inspection, the door lock mechanism was loose in such a way that the door lock lever had a double angle of up and down movement.If the lever was moved upwards, it was scraping off the protrusion on the door.Another issue was found with the door hinge spindle.The door was moving on the hinge spindle even when it was supported by the stop.Based on the performed bathtub evaluation there were several parts, which defects could have led to the reported malfunction.The customer requested to exchange the whole device, but decided to keep it until the new bath is delivered.Upon the course of investigation it was determined that the bath was installed in such a way that the front of the bath (where the feet of the client are placed) was positioned towards the wall.The distance from the wall was chosen, so that the door does not strike the wall when the door is tilted.However, due to a loosening in the hinge pivot, set range of door opening failed and bathtub's door hit the wall.According to the qualified arjo representative, there was a very limited space between wall and the bathtub, which prevent any person from access to this area.Based on the information gathered upon inspection performed on-site by the qualified arjo representative, it was not possible to determine what caused loosening of the locking mechanism and hinge pivot.The extended evaluation of the whole device is necessary to find the cause.Arjo is trying to arrange the bath return from the customer and perform more deep investigation.If results of the investigation will shed new light on the existing investigation findings (explaining the cause of the components loosening) the investigation would be updated and follow-up report will be provided.The parker bath is intended for assisted bathing and showering of adult residents in care facilities.The bath must be used by appropriately trained caregivers with adequate knowledge of the care environment, its common practices and procedures, and in accordance with the guidelines and safety instructions in the instructions for use (ifu; 04.Al.01_9gb issued in january 2015) delivered with this device.The parker bath has a door handle that works as a door lock.The door handle needs to be aligned with the sticker showing an open or closed lock.According to the ifu: to unlock the door: press the door handle down until aligned with the sticker showing an open lock.To lock the door: press the door handle up until the handle is aligned with the sticker showing a closed lock.(this may require some physical force).The ifu provides the instructions how to use door together with the supporting pictures.The parker bath is subject to wear and tear, and the following actions must be performed when specified to ensure that the product remains within its original manufacturing specification.Please note that according to ifu the caregiver should check door operation on a weekly basis: "check door/seal: open and close the door and check its supports for correct function i.E.The door should not drop by itself during closing.Check the lock for proper function." moreover, checks of the device before each use are recommended.If any part is missing or damaged the customer should remove device from use.In summary, according to the customer allegation, the bath door opened unintended and hit the wall.As per information collected upon the investigation, the door opening components were not functioning correctly and from that perspective, the bathtub was not according to the manufacturer's specification.This complaint was decided to be reported to the competent authorities in abundance of caution due to the customer allegation that the door opened suddenly during use, which under specific conditions, may create a hazardous situation to the resident or user.
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Manufacturer Narrative
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It was initially reported that during use the bath's door lock disengaged, the door unlocked unintended, then flipped out and made a mark on the wall.The customer stated that at the closing of the bathtub's door, by the handle there are symbols of "locked" and "unlocked" door.The handle always remained within these symbols.However, at this time the customer noticed that the handle did not stop at the "locked" symbol, but was going further.No injury occurrence was reported as a consequence of this event.The device was removed from usage and arjo qualified representative performed inspection.According to the results of inspection, the door lock mechanism was loose in such a way that the door lock lever had a double angle of up and down movement.If the lever was moved upwards, it was scraping off the protrusion on the door.Another issue was found with the door hinge spindle.The door was moving on the hinge spindle even when it was supported by the stop.Based on the performed bathtub evaluation there were several parts, which defects could have led to the reported malfunction.The customer requested to exchange the whole device.Upon the course of investigation it was determined that the bath was installed in such a way that the front of the bath (where the feet of the client are placed) was positioned towards the wall.The distance from the wall was chosen, so that the door does not strike the wall when the door is tilted.However, due to a loosening in the hinge pivot, set range of door opening failed and bathtub's door hit the wall.According to the qualified arjo representative, there was a very limited space between wall and the bathtub, which prevent any person from access to this area.Based on the information gathered upon the bath's inspection performed on-site by the qualified arjo representative, it was not possible to determine what caused loosening of the locking mechanism and hinge pivot.The extended evaluation of the whole device was necessary to find the cause.Arjo arranged the bath return from the customer facility to perform in-depth investigation.The inspection of the involved parker bath and analysis of the gathered information were performed at the manufacturing site.According to originator the door handle did not stop at symbol 'unlocked', but it was possible to be moved further than it should be.Based on the manufacturing analysis this could have happened because the door was tried to be closed at customer's place with an excessive force.Therefore a handle made scratches on the door lock and a laminate and a screw on the door handle become twisted.Due to twisted screw a handle became 'loose' and moved up-down more than it should.Due to damages the door handle and a lock required replacement.Scratched laminate at the door key and damaged surface at the edge of the door were repaired as well.Upon check of the door mechanism (including hinge), it was found that the door hinge on the shaft was not fastened.If the hinge is not fastened, the door will jump up automatically.When the hinge was fastened with a torque key, the door did not jump up anymore.The bracket itself and a screw on it were twisted, so the mechanism could not operate as it should.This issue could have been caused by improper procedure of door adjustment.During adjustment of the door it cannot be opened in the highest position.If the door is in the highest position a collision between hinge and stop bolt would occur.If there is a collision and the door is being adjusted, it may bend a bracket.If the door is not on the highest position there is no collision and the door can be adjusted with no danger to cause any damage.The parker bath is intended for assisted bathing and showering of adult residents in care facilities.The bath must be used by appropriately trained caregivers with adequate knowledge of the care environment, its common practices and procedures, and in accordance with the guidelines and safety instructions in the instructions for use (ifu; 04.Al.01_9gb issued in january 2015) delivered with each device.The parker bath has a door handle that works as a door lock.The door handle needs to be aligned with the sticker showing an open or closed lock.According to the ifu: - to unlock the door: press the door handle down until aligned with the sticker showing an open lock.- to lock the door: press the door handle up until the handle is aligned with the sticker showing a closed lock.(this may require some physical force).The ifu provides the instructions how to use door together with the supporting pictures.The parker bath is subject to wear and tear, and the following actions must be performed when specified to ensure that the product remains within its original manufacturing specification.Please note that according to ifu the caregiver should check door operation on a weekly basis: "check door/seal: open and close the door and check its supports for correct function i.E.The door should not drop by itself during closing.Check the lock for proper function." moreover, checks of the device before each use are recommended.If any part is missing or damaged the customer should remove device from use.In summary, according to the customer allegation, the bath door opened unintended and hit the wall.As per information collected upon the investigation, the door opening components were not functioning correctly and from that perspective, the bathtub was not according to the manufacturer's specification.This complaint was decided to be reported to the competent authorities in abundance of caution due to the customer allegation that the door opened suddenly during use, which under specific conditions, may create a hazardous situation to the resident or user.
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Search Alerts/Recalls
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