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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHRT G5 KIT,AUTO,INTL ENG-ARABIC,CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR

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CARDIAC SCIENCE CORPORATION POWERHRT G5 KIT,AUTO,INTL ENG-ARABIC,CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5A-06C
Device Problems Self-Activation or Keying (1557); Unintended Electrical Shock (4018)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device self discharged and the doctor received an unintended delivery of energy.Complainant indicated that there was no adverse effect to the patient and no information on the effects to the attending doctor due to the reported malfunction.
 
Manufacturer Narrative
The device was not received at zoll medical corporation for evaluation.Instead, the device logs were provided for evaluation.It is important to note that the device in use by this customer is an aed automatic device and is designed to analyze, prompt and provide a shock if necessary without input from the user.Review of the device activity logs for the customer's report of "device self discharge (without providing a warning prior to shock)" showed that there were multiple shock deliveries that occurred during this event.For each delivery, the shock was preceded by an analysis, a proper charge sequence and prompts both before and after the logged shocks.The customer later confirmed that the voice prompts were noted to be operational.The customer's report of "electrical shock to user" was attributed to the doctor being in contact with the patient at the time of the shock delivery.Review of the device logs did determine that the device performed as intended but certain factors cannot be determined without an actual evaluation of the device itself.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
POWERHRT G5 KIT,AUTO,INTL ENG-ARABIC,CPRD
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
MDR Report Key12109183
MDR Text Key259694614
Report Number2112020-2021-00669
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 06/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberG5A-06C
Device Catalogue NumberG5A-06C
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/14/2021
Initial Date FDA Received07/02/2021
Supplement Dates Manufacturer Received06/14/2021
Supplement Dates FDA Received08/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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