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

Model Number X SERIES

Device Problems Unable to Obtain Readings (1516); Electrical Shorting (2926)

Patient Problem Necrosis (1971)

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 treat a patient (age & gender unknown), the device displayed a "short detected" message.Complainant indicated that the clinician obtained a non-zoll device to continue treating the patient.Complainant indicated that the patient subsequently expired.

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 a non-zoll device to continue treating the patient.Complainant indicated that the patient was deceased prior to medics being present on the scene.When the patient arrived at the hospital, it was confirmed by the core temperature that the patient was deceased for a long period of time.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Evaluation: the device was not returned to zoll medical corporation for evaluation.Instead, the device log was provided.Review of the device log did show the error message related to the customer's report.However, short detected/check pads messages do not necessarily indicate a device malfunction.It is normal operation of the device if the device detected a closed circuit between the device and the accessories connected.The check pads message appears to occur in unison with the cpr activity.This suggests poor patient coupling from the electrode pads to the patient.However, without the device, cable, and used pads, the root cause cannot be determined.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: 12177698
• MDR Text Key: 261830393
• Report Number: 1220908-2021-02224
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death