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

Model Number X SERIES

Device Problem Sparking (2595)

Patient Problem Necrosis (1971)

Event Date 02/29/2024

Event Type  Death  

Event Description

Complainant alleged that while attempting to defibrillate a 70-year-old male patient, sparking was seen from the associated defib pad.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The device and multifunction cable (mfc) were returned to zoll medical corporation for evaluation.The defib pads used during the event were not returned for evaluation.The device was put through extensive testing using the customer's returned mfc without duplicating the report.Review of the device log shows a large difference between the measured impedances which is evidence of poor coupling between the patient and the electrodes being used.The first discharge had a discharge impedance of 106 ohms and delivered 256.3 joules.The second discharge had a discharge impedance of 217 ohms and delivered 304 joules.This second shock resulted in the customer's report of the pad sparking.Despite the shock, the discharge appeared to have been successful which was further confirmed through communication with the customer.It was confirmed that therapy was delivered to the patient.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Zoll recommends that patients are cleaned and hair is clipped prior to applying electrode pads to assure good coupling of electrode to skin contact.Poor adherance and/or air under the electrodes can lead to the possibility of arcing/sparking.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: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 18958288
• MDR Text Key: 338341525
• Report Number: 1220908-2024-01090
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019259
• UDI-Public: 00847946019259
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

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
• 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: 03/12/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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 Outcome(s): Death
• Patient Age: 70 YR
• Patient Sex: Male