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

Model Number	630-2231212-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The device performed to specification.A review of the device log indicates the customer was not in the correct lead view.The device was in lead ii during the patient event and the user never changed to pads view.Had the user changed to the correct view or selected any defib related key the device would have displayed the ecg signal in pads view.The device functioned as intended.The device was recertified 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 defibrillate a 78-year-old female patient, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• 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: 20299812
• Report Number: 1220908-2024-03480
• Device Sequence Number: 15401679
• Product Code: MKJ
• UDI-Device Identifier: 00847946029630
• UDI-Public: (01)00847946029630
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: Health Professional
• Device Model Number: 630-2231212-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/25/2024
• 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
• Patient Age: 78 YR
• Patient Sex: Female