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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 Failure to Deliver Shock/Stimulation (1133)
Patient Problems Necrosis (1971); Insufficient Information (4580)
Event Date 07/30/2021
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 patient (age & gender unknown), the device failed to discharge. Complainant indicated that the clinician obtained another device to continue treating the patient. Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
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Brand NameX SERIES
Type of DeviceDEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key12388125
MDR Text Key268812357
Report Number1220908-2021-02842
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112432/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2021
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? 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
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2020
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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