IABP DATASCOPE PDF

Devices Recalled in the U. If battery maintenance is not performed per the Operating Instructions Manual for each IABP, the battery may not provide the expected minimum run time of operating power. If a patient requires life-supporting therapy with an IABP and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death. No product return is required. The notice instructed customers to: Ensure the IABP is plugged into an AC power outlet when the system is not in use and whenever possible during patient use.

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Devices Recalled in the U. If battery maintenance is not performed per the Operating Instructions Manual for each IABP, the battery may not provide the expected minimum run time of operating power.

If a patient requires life-supporting therapy with an IABP and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death.

No product return is required. The notice instructed customers to: Ensure the IABP is plugged into an AC power outlet when the system is not in use and whenever possible during patient use. Batteries should be replaced: After reaching the maximum number of charge-discharge cycles. When the battery provides less than the minimum specified run time. If the battery is broken, cracked, leaking or damaged. When the labeled lifetime of the battery is reached. Replacement batteries can be ordered through your sales or service representative.

The Battery test due date or Battery Replacement Date predate the current system date at startup or the internal battery has a total accumulated discharge time in excess of total discharge cycles. Ensure only Datascope approved or sourced batteries are installed and used for all replacement batteries. Health care providers, facilities, servicers, and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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Maquet DataScope CS300 Intra-Aortic Balloon Pump

Complications[ edit ] Since the device is placed in the femoral artery and aorta it could provoke ischemia , and compartment syndrome. The leg is at highest risk of becoming ischemic if the femoral artery it is supplied by becomes obstructed. Placing the balloon too distal from the aortic arch may induce occlusion of the renal artery and subsequent kidney failure. Other possible complications are cerebral embolism during insertion, infection, dissection of the aorta or iliac artery , perforation of the artery and bleeding in the mediastinum. Mechanical failure of the balloon itself is also a risk which entails vascular surgery to remove under that circumstance.

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