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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION RESPONDER 2000, PACING, BRZ PORT AUTOMATED EXTERNAL DEFIBRILLATORS

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CARDIAC SCIENCE CORPORATION RESPONDER 2000, PACING, BRZ PORT AUTOMATED EXTERNAL DEFIBRILLATORS Back to Search Results
Model Number 2026109-004
Device Problem Failure to Charge (1085)
Patient Problem Necrosis (1971)
Event Date 07/19/2021
Event Type  Death  
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 defibrillate a (b)(6) year-old male patient, the device failed to charge. Complainant indicated that the patient subsequently expired.
 
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Brand NameRESPONDER 2000, PACING, BRZ PORT
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key12387934
MDR Text Key268800150
Report Number2112020-2021-00852
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K052316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number2026109-004
Device Catalogue Number2026109-004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2008
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: 08/30/2021 Patient Sequence Number: 1
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