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

Model Number	30001000001130013
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The device passed all functional testing.The device does not understand if the patient is conscious, is breathing, or has a pulse.When the device advised shock on the patient, energy should not have been delivered.It was explained to the customer the limitations of the product and it is the responsibility of the trained operator to know when it's appropriate to deliver a shock.The r series operator's guide, page iii -indication for use states: 'the r series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by: unconsciousness, absence of breathing, absence of pulse." the device was recertified for clinical use and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to monitor a patient (age & gender unknown), the patient developed a pulse and the device issued a "shock advised" prompt for a heart rhythm they believed was non-shockable.The clinician subsequently administered the shock to the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• 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: 21503494
• Report Number: 1220908-2025-00655
• Device Sequence Number: 20823826
• Product Code: MKJ
• UDI-Device Identifier: 00847946017194
• UDI-Public: (01)00847946017194
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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: 30001000001130013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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: Other
• Patient Sex: Unknown