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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,AUTO,CANT-INTL EN; AUTOMATED EXTERNAL DEFIBRILLATOR
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CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,AUTO,CANT-INTL EN; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5A-37A
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that during training by facility staff, the device displayed a "-d1b" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation; the customer's report was duplicated and attributed to a faulty integrated circuit on the main board.The main board was replaced to resolve the report.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
 
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Brand Name
POWERHEART G5 KIT,AUTO,CANT-INTL EN
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
MDR Report Key12481562
MDR Text Key272868281
Report Number2112020-2021-00888
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberG5A-37A
Device Catalogue NumberG5A-37A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Was the Report Sent to FDA? No
Date Manufacturer Received08/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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