• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number X SERIES
Device Problem Failure to Deliver Shock/Stimulation (1133)
Patient Problem Necrosis (1971)
Event Date 03/10/2024
Event Type  Death  
Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, defib cycling, and battery testing without duplicating the report.An internal inspection of the device found no discrepancies.The log shows the device recognized a battery recalibration condition.This is not an indication of a device malfunction, but that the battery needs to be calibrated to the capacity it can supply based on factors like age.The battery nor any other cables or accessories were returned for evaluation.The battery connection hardware was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.
 
Event Description
Complainant alleged that while attempting to defibrillate 54-year-old male patient, the device was charged to 190 joules but failed to discharge.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key19007551
MDR Text Key338951460
Report Number1220908-2024-01113
Device Sequence Number1
Product Code MKJ
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 03/11/2024
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 Health Professional
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received03/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2012
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;
Patient Age54 YR
Patient SexMale
-
-