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U.S. Department of Health and Human Services

Class 1 Device Recall Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care

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  Class 1 Device Recall Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care see related information
Date Initiated by Firm February 07, 2014
Date Posted March 28, 2014
Recall Status1 Terminated 3 on August 17, 2015
Recall Number Z-1298-2014
Recall Event ID 67502
510(K)Number K093633  K093632  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
Code Information all lots
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Customer Support
215-721-5400
Manufacturer Reason
for Recall		 The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
FDA Determined
Cause 2		 Component design/selection
Action Drager sent an Urgent Medical Device Recall letter dated February 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an affected device for patient transport only if absolutely necessary; not to rely on the battery charge status indicator, always supervise the patient and the ventilator during transport; ensure that they have a manual breathing bag available for manual ventilation as recommended in the instructions for use. If the power fail alarm occurs during transport, immediately provide manual ventilation and connect ventilator to a wall power source to resume ventilation. DragerService representative will schedule the implementation of a permanent solution as quickly as possible. The 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. Customers with questions were instructed to call 1-800-543-5047. For questions regarding the operation and/or servicing of their Draer ventilator contact Technical Support at 1-800-543-5047. For questions regarding this recall call 215-721-5400.
Quantity in Commerce 1544
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = Draegerwerk AG & Co. KGaA
510(K)s with Product Code = CBK and Original Applicant = DRAGER MEDICAL AG & CO. KGAA
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