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	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device gave 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
The device was not returned to zoll medical corporation for evaluation.Instead, the data file of the customer's report was provided.Review of the data file shows that during the analysis, both segments matched ventricular fibrillation, which would normally be considered a shockable rhythm by the analysis algorithm.However, this device has the shock conversion estimator (sce) function enabled which can override a shockability decision under certain circumstances.The sce function looks at the waveform spectrally and determines its probability to be converted to an organized rhythm.In this case, the sce determined that this rhythm was unlikely to be converted with cardioversion and it altered the algorithm's decision and changed the analysis result to "no shock advised".The investigation concluded that the device met specifications and performed as designed.Analysis of reports of this type has not identified an increase in trend.

• 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: 12699146
• Report Number: 1220908-2021-03637
• Device Sequence Number: 17107490
• Product Code: MKJ
• UDI-Device Identifier: 00847946019945
• UDI-Public: 00847946019945
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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