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

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Information (3190)

Event Date 11/24/2020

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed a "check pads" message.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

The device was returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The device passed all testing including full functionality testing and stress testing without duplicating the report.Review of the device log on the reported event date of 11/24/2020 shows that there were cpr pads attached to the device.The device was in rescue mode and auto selected to the correct lead view.Two seconds after the impedance was acquired, it was lost and the pads registered as off.There are several connects and disconnects based on the defib id's which appear to be troubleshooting, but a signal was not acquired again for the duration of the case.This may indicate there is a coupling issue when the pads are attached to the patient, or as the customer indicated, an issue with the electrode pads.The customer indicated a wire may have been detached from the electrode pads, but they were not returned as part of the investigation.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
• MDR Report Key: 11097581
• MDR Text Key: 224522455
• Report Number: 1220908-2020-04417
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019143
• UDI-Public: 00847946019143
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 12/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1