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

Model Number	30001004101110012
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation.During the investigation it was noted that no event date was provided.The device logs were reviewed and observed no critical errors that would prevent the device from shocking or showing a heart rate.There were no indications of a device malfunction.The device passed all functional tests including stress tests, shock testing, and bench handling using test cables and a simulator with no discrepancies noted.No ecg-related accessories were returned for evaluation.The repair recommendation is to recertify the device.The claim will be closed as no fault found.No emerging trend based on similar reports.
Event or Problem Description
Complainant alleged that during biomed testing, the device failed to discharge.Complainant indicated that there was no patient involvement in 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.

• Brand Name: R 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: 24188420
• Report Number: 1220908-2026-00076
• Device Sequence Number: 18583601
• Product Code: MKJ
• UDI-Device Identifier: 00847946017439
• UDI-Public: (01)00847946017439
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/06/2026

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: 30001004101110012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/20/2026
• 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
• Patient Sex: Unknown