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

Model Number	X SERIES
Medical Device Problem Codes	Unable to Obtain Readings (1516); Capturing Problem (2891)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 treating a (b)(6) female patient, the device did not display an ecg signal and was unable to capture the patient's heart rhythm.Complainant indicated that there was no adverse effects to the patient due to the reported malfunction.The patient converted on her own.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation for evaluation.Instead, a zoll field representative went onsite to troubleshoot.The zoll representative determined that the ecg leads were not attached to the patient.By design, the device will not pace in demand mode without seeing an ecg signal through leads.The clinical data was not available for review as part of the investigation.This report has been attributed to improper use of the device by the end user.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7434510
• Report Number: 1220908-2018-01020
• Device Sequence Number: 1417041
• Product Code: MKJ
• UDI-Device Identifier: 00847946006327
• UDI-Public: 00847946006327
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112432
• 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): 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR