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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER

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ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number X SERIES
Device Problems Failure to Deliver Shock/Stimulation (1133); Sparking (2595)
Patient Problem Cardiac Arrest (1762)
Event Date 03/13/2024
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown) in cardiac arrest, the device successfully delivered one shock.The device then failed to discharge a second shock.A new set of electrode pads were applied to the patient and the selected energy was delivered.However, on a subsequent shock there was a spark seen from the pads.The electrodes were replaced again to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
Zoll medical united kingdom evaluated the device for the report of unable to discharge and sparked.The device was put through extensive testing including functional testing, defib/pacer stress testing, bench handling, and defib cycling without duplicating any malfunction to the device.The device was recertified and returned to the customer.The log showed the device is charged but is in a defib lead fault state before being able to discharge on the third attempt.A defib lead fault indicates an invalid patient impedance but was ultimately achieved based on the delivery of therapy on the third shock attempt.This third shock to the patient indicated poor coupling which likely led to the spark observed.Poor coupling can be caused by various factors including but not limited to electrode placement, poor patient preparation, or just poor contact between the pad and patient.Poor coupling can lead to air pockets forming between the electrodes and the patient which can cause sparking, burning smell, and pop sound.The x series operator's guide states, 'do not use therapy or ecg electrodes if the gel is dried, separated, torn, or split from the foil; patient burns may result from using such electrodes.Poor adherence and/or air pockets under therapy electrodes can cause arcing and skin burns.' analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
X SERIES
Type of Device
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key19191659
MDR Text Key341145989
Report Number1220908-2024-01603
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P160022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/12/2024
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
Device Operator Other
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/12/2024
Initial Date FDA Received04/26/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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