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

Model Number	X SERIES
Medical Device Problem Codes	Failure to Charge (1085); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	11/11/2022
Type of Reportable Event	Death
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 75-year-old male patient, the device was unable to detect the attached electrodes pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a 75-year-old male patient, the device was unable to detect the attached electrodes pads and the device did not deliver energy.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (medical device problem code).Device evaluation: zoll medical corporation evaluated the device and the device performed to specification.The device passed all testing successfully, was recertified, and returned to the customer.Review of the device logs confirmed the device delivered energy into a patient impedance of 133ohms.Even though patient movement is typical when delivering energy, it is not an indicator of energy being delivered.Review of the device log for customer's report of no ecg through electrode pads was observed in the log as pacer mode was entered, which auto selected lead ii.When in pacer mode the pads lead view is not selectable.Had pacer mode been exited and lead view switched to pads, the signal would have displayed.There is no indication that the device could not recognize the pads attached.The report was attributed to the end user inadvertently switching to pacer/lead ii mode.No trend is associated with reports of this type.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 15932451
• Report Number: 1220908-2022-04727
• Device Sequence Number: 12402752
• Product Code: MKJ
• UDI-Device Identifier: 00847946020477
• UDI-Public: 00847946020477
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 11/16/2022

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
• Operator of Device: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2018
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Sex: Male