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Model Number 6100 |
Device Problem
Device Tipped Over (2589)
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Patient Problem
Abrasion (1689)
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Event Date 12/31/2022 |
Event Type
Injury
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Event Description
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It was reported that during the course of an intensive care transfer with the rescue and intensive care transport helicopter, a critically ill patient with circulatory instability was on the way from the hospital building to the helipad, when the cot tipped over sideways with the patient.The cot was guided at the front by the emergency paramedic and at the back by the emergency physician.Three medical devices (holder with three syringe pumps, patient monitor with defib unit and the mobile oxygen bottle) were attached to the side, on the right in the direction of travel, and the ventilator was attached to the head end of the cot.By driving around obstacles (parked car, overturned construction site element and container in the access area to the landing site) and crossing a water drain, the cot with the patient weighing approx.70kg tipped over to the right (the side with the equipment) in a left turn.The cot fell onto its right side and the fall was intercepted by the equipment mounted there.This destroyed the syringe pump with the catecholamine it contained, as well as the patient monitor.The patient was secured from falling by the straps of the cot.Only their head touched the floor in the area of the forehead, resulting in a pressure mark/scrape.The cot was set up again with the patient still strapped to it and the patient was driven back to the hospital/shock room.In the shock room, with the help of the emergency room team there, the monitoring was reinstalled and showed a treatment pattern requiring resuscitation.Resuscitation measures and the appropriate medication were started immediately.After 30 minutes of unsuccessful resuscitation, the measures were discontinued by consensus of all physicians present, and the patient's death was documented.Further information is being requested to determine if the patients pre-existing condition and/or the device contributed to the patients death.
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Event Description
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It was reported that during the course of an intensive care transfer with the rescue and intensive care transport helicopter, a critically ill patient with circulatory instability was on the way from the hospital building to the helipad, when the cot tipped over sideways with the patient.The cot was guided at the front by the emergency paramedic and at the back by the emergency physician.Three medical devices (holder with three syringe pumps, patient monitor with defib unit and the mobile oxygen bottle) were attached to the side, on the right in the direction of travel, and the ventilator was attached to the head end of the cot.By driving around obstacles (parked car, overturned construction site element and container in the access area to the landing site) and crossing a water drain, the cot with the patient weighing approx.70kg tipped over to the right (the side with the equipment) in a left turn.The cot fell onto its right side and the fall was intercepted by the equipment mounted there.This destroyed the syringe pump with the catecholamine it contained, as well as the patient monitor.The patient was secured from falling by the straps of the cot.Only their head touched the floor in the area of the forehead, resulting in a pressure mark/scrape.The cot was set up again with the patient still strapped to it and the patient was driven back to the hospital/shock room.In the shock room, with the help of the emergency room team there, the monitoring was reinstalled and showed a treatment pattern requiring resuscitation.Resuscitation measures and the appropriate medication were started immediately.After 30 minutes of unsuccessful resuscitation, the measures were discontinued by consensus of all physicians present, and the patient's death was documented.
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Manufacturer Narrative
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It was reported that at the time of the event, various environmental and preexisting factors may have caused or contributed to the cot tip including obstacles in the path, strong whether, darkness, and the patient initially being in critical respiratory condition (on a ventilator).An inspection on the device was performed by a third party.It was identified using information provided by the customer that the most likely cause for the cot tip was no component level defect in the device.H3 other text : device evaluated by a third party.
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Search Alerts/Recalls
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