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

Model Number	X SERIES
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/15/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a (b)(6) year old female patient, the device did not recognize the attached electrode pads.Complainant indicated that the clinician obtained another device and another set of electrode pads to continue treating the patient.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation as it relates to the monitor.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.The device was not returned to zoll medical corporation for evaluation instead the cpr stat pads adult electrodes with lot number #1517 was received unopened in its original packaging.These are not the event electrodes, but from the same lot as the electrodes used.Inspection of pads found no discrepancies.The electrode pads were subjected to several functionality tests including various shock discharges at 30, 50, 100, 150, and 200j.Review of device's history log indicates a "defib pad lead fault message" consistent with the customer report.There was no indication that an attempt was made to deliver therapy.No device errors were observed as part of the review but we do observe the device having difficulty identifying the electrode set.Identification does not impact the devices ability to deliver therapy.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Please reference medwatch report 1218058-2018-00115 regarding the pads involved during the same event reported from the same customer.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting additional information: this mdr was inadvertently submitted with the incorrect device and manufacturer information.The customer later reported that they are not alleging a malfunction of the x series device used in this event, rather they believe the issue was with the electrode pads (reference mfr report# 1218058-2018-00115).

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8139471
• Report Number: 1220908-2018-03537
• Device Sequence Number: 16580929
• Product Code: MKJ
• UDI-Device Identifier: 00847946006389
• UDI-Public: 00847946006389
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018; 11/15/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 12/26/2018; 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 33 YR