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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 AED AUTOMATIC AUTOMATED EXTERNAL DEFIBRILLATOR (AED)

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CARDIAC SCIENCE CORPORATION POWERHEART G5 AED AUTOMATIC AUTOMATED EXTERNAL DEFIBRILLATOR (AED) Back to Search Results
Model Number G5A
Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Apnea (1720)
Event Date 11/30/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is in process. Data was downloaded from the aed and is being reviewed.
 
Event Description
A (b)(6) month old baby was brought into a walk in centre (wic) by the mother. The triage nurse noted the baby was mottled and blue. The nurse took the baby, shouted for help, and an ambulance was called. Baby was having apneic episodes, but a pulse was still present. Nursing staff delivered stimulation to the baby and the baby started to breathe, but was still having apneic episodes; rescue breaths were not administered. Aed pads were applied in the a-p position on the baby and the rhythm analysis stated no shock advised. After approximately seven (7) minutes, the aed analyzed the baby's rhythm, stated shock advised, and a shock was given. The staff reported the baby was breathing and had a pulse throughout the event. The customer wants to know if there was an issue with the analysis of the rhythm and why the aed shocked when it did as there were complexes on the ecg trace. The baby was transferred to the hospital and was still alive when the event was reported to cardiac science.
 
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Brand NamePOWERHEART G5 AED AUTOMATIC
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR (AED)
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
Manufacturer (Section G)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
Manufacturer Contact
margo gisselberg
500 burdick parkway
deerfield, WI 53531-9692
2629537950
MDR Report Key9462188
MDR Text Key188408896
Report Number2112020-2019-00025
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P160033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG5A
Device Catalogue NumberG5A-02A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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