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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD AUTOMATED EXTERNAL DEFIBRILLATOR

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CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5S-80C
Device Problem Unable to Obtain Readings (1516)
Patient Problem Necrosis (1971)
Event Type  Death  
Manufacturer Narrative
Zoll medical corporation has received both products and will be providing a supplemental report when our investigations are completed.
 
Event Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), using device sn (b)(4), the device was unable to detect the electrode pads. Complainant indicated that the clinician reapplied the pads with no change. They then attempted a reset of the aed with no change. They obtained another set of electrode pads with no change. The clinician's obtained another device sn (b)(4) that also was unable to detect the electrode pads. The crew performed continuous high quality cpr to continue treating the patient. Complainant indicated that the patient subsequently expired.
 
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Brand NamePOWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key12516404
MDR Text Key272849621
Report Number2112020-2021-00921
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberG5S-80C
Device Catalogue NumberG5S-80C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/22/2021 Patient Sequence Number: 1
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