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

Model Number X SERIES

Device Problems Failure to Deliver Shock/Stimulation (1133); Arcing of Electrodes (2289)

Patient Problem No Information (3190)

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 defibrillating a patient (age & gender unknown), an arc was seen from the electrode pads.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.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: the device was returned to zoll medical (b)(4)'s service department.The reported malfunction of "unable to discharge" and "arching" was not replicated or confirmed.The device and multi-function cable passed bench handling, defib and impedance testing without duplicating the reported malfunction.The customer did report that the user successfully shocked twice and was unable to discharge on the third attempt.After power cycling the device, the device discharged but the user reported the arcing.Review of the device activity logs showed the first successful shock with an impedance of 155 ohms and the second shock recorded 186 ohms.During the third charge cycle, the device prompted a "charge lead fault" and pads off message.By the time the device finished charging the device records a pads on.The device showed this impedance at 258 ohms, however there was no indication that a discharge was attempted.The device power was cycled and the device charged again.The device successfully discharges and reads an impedance of 275 ohms.Throughout the case, when the device registers pads on, the impedance fluctuates in time with cpr being performed.The impedance fluctuations and log review is consistent with poor contact between the electrode pads and the patient's skin.This can also contribute to arcing.However, the electrode pads used were not returned as part of this investigation and this cannot be firmly established.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while defibrillating a patient (age & gender unknown), device was unable to discharge and an arc was seen from the electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: X SERIES
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 8678117
• MDR Text Key: 147303905
• Report Number: 1220908-2019-01546
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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