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

Model Number	X SERIES
Medical Device Problem Codes	Delayed Charge Time (2586); Device Operational Issue (2914)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/17/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to monitor a (b)(6) male patient, the device delayed to charge and internally dumped the energy after charging up to defibrillate the patient.Complainant indicated that the patient subsequently expired, however they believe it was not a result of the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the customer's report for device slow to charge was observed during review of the device's activity log.However, the reported problem could not be duplicated with the device.The battery used during the event was not returned as part of the investigation.The battery pin connection hardware was replaced as a precaution.The device was recertified and returned to the customer.Review of the activity logs for the customer's report the device disarmed itself was confirmed ; however the device performed to specification.The device is designed to internally discharge once a charge attempt exceeds 25 seconds.This occurred on both second and third charge attempts since the charge time exceeded 25 seconds.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7514637
• Report Number: 1220908-2018-01329
• Device Sequence Number: 1529280
• Product Code: MKJ
• UDI-Device Identifier: 00847946004330
• UDI-Public: 00847946004330
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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: 35 YR