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

Model Number	30001007201310013
Medical Device Problem Codes	Pacing Problem (1439); Failure to Power Up (1476); Defibrillation/Stimulation Problem (1573); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed unknown error messages, then would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Please reference sections b5 and h6: medical device problem codes.Evaluation results: the device was returned to zoll medical corporation.During the investigation it was noted that the report of "system fault code 36", "system fault code 37", "defib disabled", and "pacer fault" were observed and attributed to a loose primary side ecg shield on the analog board.The analog board was replaced and scrapped to resolve the report.The customer's report of no power was observed during initial testing.However, it could not be duplicated with the device.The digital board was replaced and scrapped as a precaution.The device was recertified and returned to the customer.No emerging trend based on similar reports.
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed "system fault 36", "system fault 37", "defib disabled", and pacer fault messages, then would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: R SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford WI 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 24234340
• Report Number: 1220908-2026-00221
• Device Sequence Number: 10188067
• Product Code: MKJ
• UDI-Device Identifier: 00847946017620
• UDI-Public: (01)00847946017620
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/15/2026

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: 30001007201310013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2017
• 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