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

Model Number	X SERIES
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/18/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a (b)(6) patient (gender unknown) in critical arrest, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The device's activity log was returned to zoll medical corporation; review of the device log confirms the end user had good contact and a signal displayed with the one-step electrodes.Once switched to pacer mode, which must be viewed through ecg monitoring leads, the signal was lost.We can confirm that the ecg leads are attached to the device, but cannot confirm if they were attached to the patient.There are many factors that may lead to having no ecg signal displayed, electrodes never being attached to the patient, damaged/defective ecg cable, poor patient prep, and poor coupling even though on-demand pacing requires a high quality ecg signal, it is important to note that the device was capable of "fixed" pacing (device bypasses ecg signal and provides consistent pacer pulses) had the attempt been made.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: 8147657
• Report Number: 1220908-2018-03547
• Device Sequence Number: 16508636
• Product Code: DRT
• UDI-Device Identifier: 00847946004330
• UDI-Public: 00847946004330
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 11/19/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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: 65 YR