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Model Number MEERA |
Device Problem
Device Fell (4014)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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At the time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.The full event site name is: (b)(6).
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Event Description
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We have received the user report "facility medwatch (b)(4)" from the fda.In this report an issue with one of our tables and head rests was described.The affected table is a mobile operating table of the "meera" model line.To this operating table several different models of head rests can be attached.We have requested further information concerning the affected products and the course of events from the customer, but not received them yet.The following was reported to us (direct quote from the medwatch): "after turning the meera bed used for neuro surgery 180 degrees for the purpose of the surgery, the head of the bed became completely detached and fell to the floor.The patients head was resting on the head portion of the bed and as a result, fell with it and the neck hyper extended.Patient was woken up enough to do a minimal neuro exam to ensure she could follow commands and move all four extremities.Patient was placed in a c-collar and more intense neuro exam was completed at the end of surgery.The patient could have broken her neck, or worse become paralyzed.The bed is either broken or was not attached properly by whoever set up the room." no injury of the patient was reported to us.
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Manufacturer Narrative
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A getinge-maquet service technician has visited the clinic and investigated the affected table and also other tables in hospital.The described malfunction could not be reproduced.No defect or malfunction was found on the table.Further information concerning this incident was requested from the clinic, but not provided.A use error cannot be excluded.The user is warned as follows in the instructions for use (ifu) concerning crushing and shearing hazards: warning! risk of injury! products / accessories not attached properly may loosen and cause injuries.Ensure that products / accessories are mounted correctly and that the securing elements (handle screws, catches, levers, etc.) are closed and firmly tightened, also ensure that moving parts are correctly secured.The correction of b5 describe event or problem field deems required.Previous b5 describe event or problem: we have received the user report "facility medwatch: (b)(4)" from the fda.In this report an issue with one of our tables and head rests was described.The affected table is a mobile operating table of the "meera" model line.To this operating table several different models of head rests can be attached.We have requested further information concerning the affected products and the course of events from the customer, but not received them yet.The following was reported to us (direct quote from the medwatch): "after turning the meera bed used for neuro surgery 180 degrees for the purpose of the surgery, the head of the bed became completely detached and fell to the floor.The patients head was resting on the head portion of the bed and as a result, fell with it and the neck hyper extended.Patient was woken up enough to do a minimal neuro exam to ensure she could follow commands and move all four extremities.Patient was placed in a c-collar and more intense neuro exam was completed at the end of surgery.The patient could have broken her neck, or worse become paralyzed.The bed is either broken or was not attached properly by whoever set up the room." no injury of the patient was reported to us.Corrected b5 describe event or problem: we have received the user report "facility medwatch (b)(4)" from the fda.In this report an issue with one of our tables and head rests was described.The affected table is a mobile operating table of the "meera" model line.To this operating table several different models of head rests can be attached.We had requested further information concerning the affected products and the course of events from the customer, but did not received them.The following was reported to us (direct quote from the medwatch): "after turning the meera bed used for neuro surgery 180 degrees for the purpose of the surgery, the head of the bed became completely detached and fell to the floor.The patients head was resting on the head portion of the bed and as a result, fell with it and the neck hyper extended.Patient was woken up enough to do a minimal neuro exam to ensure she could follow commands and move all four extremities.Patient was placed in a c-collar and more intense neuro exam was completed at the end of surgery.The patient could have broken her neck, or worse become paralyzed.The bed is either broken or was not attached properly by whoever set up the room." no injury of the patient was reported to us.
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Event Description
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We have received the user report "facility medwatch: (b)(4)" from the fda.In this report an issue with one of our tables and head rests was described.The affected table is a mobile operationg table of the "meera" model line.To this operationg table several different models of head rests can be attached.We had requested further information concerning the affected products and the course of events from the customer, but did not received them.The following was reported to us (direct quote from the medwatch): "after turning the meera bed used for neuro surgery 180 degrees for the purpose of the surgery, the head of the bed became completely detached and fell to the floor.The patients head was resting on the head portion of the bed and as a result, fell with it and the neck hyper extended.Patient was woken up enough to do a minimal neuro exam to ensure she could follow commands and move all four extremities.Patient was placed in a c-collar and more intense neuro exam was completed at the end of surgery.The patient could have broken her neck, or worse become paralyzed.The bed is either broken or was not attached properly by whoever set up the room." no injury of the patient was reported to us.
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Search Alerts/Recalls
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