Welcome to a Biomedical Battery specialist of the Draeger Battery
Dräger sent their customers an Urgent Medical Device Recall letter dated February 2014. The letter identified the product, the problem, and interim action to be taken by the customer until a permanent solution is available.
As an interim solution, the batteries in the PS500 such as Draeger MS14234 Battery, Draeger Medical GAMMA Battery, Draeger Medical MS18340 Battery, Siemens SC9000XL Battery, Siemens SC7000 Battery, Siemens Medical Syste SC7000 Battery, Comen CM-100 Battery, Comen ICR18650 Battery, Comen CM-1200A Battery, Comen G60 Battery, Comen G50 Battery, Comen HYLB-1010 Battery will be replaced free of charge. Dräger service representatives are contacting customers to schedule replacement of the PS500 batteries. Until the batteries are exchanged, Dräger recommends that the user:
1.Use an affected device for patient transport only if absolutely necessary.
2.Not rely on the battery charge status indicator.
3.Always supervise the patient and the ventilator during transport. Ensure that a manual resuscitator is available for manual ventilation, as recommended in the Instructions for Use.
4.If the power fail alarm occurs during transport, immediately provide manual ventilation and connect ventilator to a wall power source to resume ventilation.
After the above mentioned battery exchange, Dräger recommends the following:
1.Minimize battery usage.
2.Avoid brief usage and charging of the PS500 (1-20 minutes)
3.Avoid patient transport lasting longer than one hour.
4.Make sure to charge the batteries for at least 24 hours.
The exchange of the existing batteries and the above recommendations are only a temporary solution to ensure a minimum operating time of 1 hour independent from the main AC power.
The permanent solution, once available, will also be provided free of charge.
The Urgent Medical Device Recall letter should be distributed to users of the Evita V500 and/or Babylog VN500 Ventilators to make them aware of this device behavior and risk mitigation measures.
No comments:
Post a Comment