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

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

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 monitor a patient (age & gender unknown), the device was unable to detect the attached electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section d9.Device evaluation: the device was returned to zoll medical corporation; the customer's report was observed during review of the device's history log.Review of the log showed the device was powered on in pads view with cpr stat pads and 4 lead ecg cable connected.The ecg view was changed to lead i and remained as is through the rest of the case.Pads were placed on the patient and a valid impedance was detected.However, because the device was in lead i, the user only sees lead fault due to no ecg leads being attached to the patient.It can be seen in the log that the defib cable was disconnected and reconnected multiple times as part of troubleshooting.The log showed a solid connection between the electrodes and the patient and had the user changed the view to pads or initiate defib mode by pressing any defib related buttons, pads signal would have been displayed.The log showed no critical errors that would have prevented the device from showing reading from pads.The device was subjected to full system level testing including ecg testing using pads and leads without any discrepancies.The device was recertified and returned to the customer.Analysis for 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
• MDR Report Key: 12489226
• MDR Text Key: 271941132
• Report Number: 1220908-2021-03005
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019259
• UDI-Public: 00847946019259
• Combination Product (y/n): N
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: 09/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1