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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 Problem Incorrect Interpretation of Signal (1543)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2024
Event Type  malfunction  
Event Description
Complainant alleged that while attempting to defibrillate a male patient (age 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.
 
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
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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 Key19174142
MDR Text Key340944134
Report Number1220908-2024-01609
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 04/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexMale
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