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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 Unable to Obtain Readings (1516)
Patient Problem Necrosis (1971)
Event Date 06/23/2023
Event Type  Death  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device was unable to detect the attached electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
 
Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device was put through extensive testing including ecg stress testing and bench handling without duplicating the report.The device was recertified and returned to the customer.The review of device logs indicated that the user was viewing in lead ii view instead of viewing with the pads/paddles view.The user would need to change to the pads view to see the ecg signal coming from the electrode pads attached to the patient.No faults identified in the log review that would suggest the device malfunctioned.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 Key17691072
MDR Text Key322741547
Report Number1220908-2023-03405
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00847946019259
UDI-Public00847946019259
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,Followup
Report Date 08/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/16/2023
Initial Date FDA Received09/06/2023
Supplement Dates Manufacturer Received08/16/2023
Supplement Dates FDA Received09/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2020
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 Outcome(s) Death;
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