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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 Fire (1245)
Patient Problems Burn(s) (1757); Necrosis (1971)
Event Date 08/28/2021
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 delivered two shocks. Upon the third shock a fire occured causing burns to the patient's face and neck. Complainant indicated that the patient subsequently expired.
 
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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 Key12491946
MDR Text Key272020959
Report Number1220908-2021-03124
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 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2020
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: 09/17/2021 Patient Sequence Number: 1
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