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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION ELECTRODES, ADULT, G5 AED
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CARDIAC SCIENCE CORPORATION ELECTRODES, ADULT, G5 AED Back to Search Results
Model Number XELAED001B
Device Problem High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during biomed testing, the associated device failed for high impedance using these electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was not returned to zoll medical corporation for evaluation.Instead, the data file of the customer's report was provided.Review of the data file did show the error message related to the customer's report.However, without receipt of the device, root cause evaluation could not be performed.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
ELECTRODES, ADULT, G5 AED
Type of Device
ELECTRODE
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key12489632
MDR Text Key273098279
Report Number2112020-2021-00893
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/28/2021
Device Model NumberXELAED001B
Device Catalogue NumberXELAED001B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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