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U.S. Department of Health and Human Services

Class 2 Device Recall Fukuda Denshi

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  Class 2 Device Recall Fukuda Denshi see related information
Date Initiated by Firm October 16, 2017
Create Date December 06, 2017
Recall Status1 Open3, Classified
Recall Number Z-0203-2018
Recall Event ID 78441
510(K)Number K134046  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Fukuda Denshi patient monitor model DS-8100M and DS-8100N

Product Usage:
Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.
Code Information all DS-8100 units manufactured and distributed worldwide.
Recalling Firm/
Manufacturer
Fukuda Denshi Co., Ltd.
2-35-8 Hongo, Bunkyo-Ku
Tokyo Japan
For Additional Information Contact Doung Blakely
206-3054460
Manufacturer Reason
for Recall
For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term battery backup).
FDA Determined
Cause 2
Component design/selection
Action The recalling firm will notify affected consignees via Field Correction Notification letter. The letter identified the affected product, problem and actions to be taken. A Customer Confirmation Sheet to be filled out by end user and faxed or emailed back to Fukuda Denshi USA, Inc will also be included. For questions call 206-305-4460.
Quantity in Commerce 6227 units
Distribution Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = FUKUDA DENSHI USA, INC.
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