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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PLUS; DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION AED PLUS; DEFIBRILLATOR Back to Search Results
Model Number AED PLUS
Medical Device Problem Code Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device issued a "shock advised" prompt for a heart rhythm they believed was non-shockable.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.
 
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Brand Name
AED PLUS
Common Device Name
DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key7565286
Report Number1220908-2018-01521
Device Sequence Number11394865
Product Code MKJ
UDI-Device Identifier00847946002169
UDI-Public00847946002169
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K011541/P160
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model NumberAED PLUS
Device Catalogue NumberAED PLUS
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/14/2018
Supplement Date Received by Manufacturer05/14/2018
Initial Report FDA Received Date06/04/2018
Supplement Report FDA Received Date07/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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