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

Model Number X SERIES

Device Problems Incorrect Interpretation of Signal (1543); Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to defibrillate a 78-year-old female patient, the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Additionally, on the fourth attempted defibrillation, an arc was seen coming from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The customer's report of "no shock advised" was observed during review of the device data logs.The third analysis did not match any specific waveform type which influenced the no shock advised determination.The information obtained from this investigation related to the third analysis was reviewed and determined to be an outlier.Based on our review of the data, we have concluded that the analysis program worked within its limitations.The report of "sparking/arcing" was observed during review of the device data logs.Each occurrence of "attach pads" is accompanied by invalid patient impedance in the log, which is evidence of poor coupling.The device was put through extensive testing including bench handling and defib cycling without duplicating the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Type of Device: 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: 16473434
• MDR Text Key: 310588112
• Report Number: 1220908-2023-00739
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946029524
• UDI-Public: 00847946029524
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female