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

Model Number	620-2211011-01
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a 48-year-old male patient, the device failed to discharge on the correct waveform.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the data file and the customer's report was not confirmed.Review of the files showed energy is delivered three seconds after reaching full charge via a button press.There are no other charge attempts in the log, and no indication of a malfunction or error.It's important to note the device was charged and discharged via user commands.The only way the device has any influence on the delivery of energy would be an analysis (shock determination) or synchronized cardioversion (specific shock timing).Since this was a defibrillation, the user was in full control of the timing and delivery of the shock.The log showed no indication that the shock output was inappropriate.No trend is associated with reports of this type.
Additional Manufacturer Narrative
This supplemental medwatch report updates information based upon your request which differs from the initial medwatch report filed.Please reference sections d4 model # updated, d4 catalog # removed, d4 primary udi # updated.

• Brand Name: X SERIES
• Common Device Name: 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 Key: 18046091
• Report Number: 1220908-2023-04162
• Device Sequence Number: 20707808
• Product Code: MKJ
• UDI-Device Identifier: 00847946019051
• UDI-Public: (01)00847946019051(21)AR21K063273
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Other
• Device Model Number: 620-2211011-01
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023; Not provided
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/21/2023; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male