MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	630-2271211-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/22/2026
Type of Reportable Event	Death
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown) in cardiac arrest, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.Event log review confirmed that ecg was initially obtained through the pads; however, the user switched to lead i rather than pads view.When the analyze button was selected near the end of the event, the device returned to pads view and a clear ecg signal was observed.Device evaluation found no malfunction; the unit passed all functional testing and produced a clear ecg signal using test accessories.The device performed as expected and designed.The reported leads and pads were not returned for evaluation.Based on log review and testing, the reported no ecg condition was attributed to wrong lead view.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; +1(978)421-9552
• MDR Report Key: 50790281
• Report Number: 1220908-2026-03577
• Device Sequence Number: 21213495
• Product Code: MKJ
• UDI-Device Identifier: 00847946029500
• UDI-Public: (01)00847946029500
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: Health Professional
• Device Model Number: 630-2271211-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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 Sex: Unknown