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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 functional testing, the associated defibrillator failed for high impedance using these attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.
 
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Brand Name
ELECTRODES, ADULT, G5 AED
Type of Device
ELECTRODES
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key18168844
MDR Text Key328526905
Report Number2112020-2023-01045
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00812394020959
UDI-Public00812394020959
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P160033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberXELAED001B
Device Catalogue NumberXELAED001B
Device Lot Number230309-10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/31/2023
Initial Date FDA Received11/20/2023
Supplement Dates Manufacturer Received10/31/2023
Supplement Dates FDA Received12/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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