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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 Reset Problem (3019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The customer's report was duplicated and the monitor board was replaced to resolve the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that during a routine shift check by a clinician, the device would restart/reboot itself multiple times.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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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 Key19120267
MDR Text Key340357387
Report Number1220908-2024-01329
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00847946029517
UDI-Public00847946029517
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 03/27/2024
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 Health Professional
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/27/2024
Initial Date FDA Received04/16/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2022
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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