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

Model Number X SERIES

Device Problems Unable to Obtain Readings (1516); Failure to Read Input Signal (1581)

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device displayed an "ecg monitoring failure" message.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report number 1220908-2023-01214 for a similar report from the same customer.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Device evaluation: zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including full functional testing and ecg stress testing without duplicating the report.The device was recertified and returned to the customer.Review of the device log showed the unit was showed mostly a flat line signal, with erroneous spikes seen throughout the case.This occurred after the unit was experiencing ecg multi lead fault.Ecg multi-lead fault is not indicative of a device malfunction, but an indication of poor connection between the electrodes and the patient.The ecg accessories used were not returned to zoll for testing.No trend is associated with reports of this type.Reports of this nature are typically not considered to meet our requirements for submission based on intended use of the device.If electrode therapy pads were connected to the patient, ecg would have been available.

Event Description

Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device's 12 lead is not functioning.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report number 1220908-2023-01214 for a similar report from the same customer.

• 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: 16682130
• MDR Text Key: 312761887
• Report Number: 1220908-2023-01215
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946004354
• UDI-Public: 00847946004354
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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