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

Model Number	620-0211511-01
Medical Device Problem Codes	Unable to Obtain Readings (1516); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to pace a patient (age & gender unknown), the device inappropriately shut down and was unable to detect the attached electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation following a report of unexpected power off during use.Investigation was limited because event logs from the reported date were unavailable and no customer log file could be recovered.Review of the available printout indicated the pacer had been paused, and two "system on" entries were identified, suggesting the device had been power-cycled.No error codes or diagnostic information were available to determine the cause of the reported shutdown.Comprehensive functional, power, and stress testing were performed, and the device operated as intended with no failures observed.Based on the available information, the reported unexpected power-off could not be confirmed, and no device malfunction was identified.The device was recertified and returned to the customer for clinical use.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 ; 9784219552
• MDR Report Key: 25374453
• Report Number: 1220908-2026-01911
• Device Sequence Number: 21496462
• Product Code: MKJ
• UDI-Device Identifier: 00847946018634
• UDI-Public: (01)00847946018634
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/14/2026

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: 620-0211511-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• 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: 05/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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 Sex: Unknown