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

Model Number	X SERIES
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device issued a "shock advised" prompt for a heart rhythm they believe was non-shockable and a "no shock advised" prompt for a rhythm clinicians believed was shockable.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 received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The customer's report was not observed during evaluatin of the device.Review of the data indicated the criteria was not met for an advised shock due to chest compressions (cpr) being performed and contributing to no shock advised.The manual states to "keep patient motionless during ecg analysis.Do not touch the patient during analysis.Cease all movement via stretcher or vehicle before analyzing the ecg".Also, review of the device clinical data confirms the device analyzed the rhythm appropriately and met the requirements of a shock advised determination.Based on our review of the data we have concluded that the analysis program results were correct for the specific analyses in question and that there was no indication of a malfunction with the device.The investigation is being closed as the device worked within the limitations of the available technology.No trend is associated with reports of this type.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 13562202
• Report Number: 1220908-2022-00547
• Device Sequence Number: 19923420
• Product Code: MKJ
• UDI-Device Identifier: 00847946019945
• UDI-Public: 00847946019945
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/28/2022

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: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2017
• 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