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

Model Number	630-2221111-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged while attempting to treat a patient in cardiac arrest (age & gender unknown), the device was unable to detect the attached electrode pads.Complainant indicated that the clinician resecured pads, then obtained another set of electrode pads to continue treating the patient with no change.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.Device logs were reviewed for evidence that the device failed to detect pads; however, no errors indicating a device malfunction were identified.Although log entries showed toggling of the defibrillation cable id, this behavior is not indicative of a device failure and is more consistent with an accessory or connectivity issue, such as improperly connected cables, adaptors, or pads.A successful short self-test was completed shortly after one of the logged events, indicating the issue resolved without device intervention.There was no evidence in the logs that pads were applied to a patient.The returned device underwent bench handling, stress, and functional testing with test accessories and passed all evaluations without reproducing the customer's report.The customer's accessories and pads were not returned for analysis; therefore, being related to an accessory-related condition cannot be ruled out.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• 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: 24277202
• Report Number: 1220908-2026-00232
• Device Sequence Number: 9802762
• Product Code: MKJ
• UDI-Device Identifier: 00847946029524
• UDI-Public: (01)00847946029524
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 01/19/2026

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: 630-2221111-01
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2018
• 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
• Patient Sex: Unknown