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

Model Number	X SERIES
Medical Device Problem Code	Failure to Discharge (1169)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	04/23/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), after three discharges, on the fourth attempt the device failed to discharge.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and multi-function cable and the device performed to specification.The device was recertified and returned to the customer.Review of the clinical data file confirmed that an initial attempt to discharge was unsuccessful and that the second attempt was delivered.The data also confirmed that the malfunction was not related to the multi-function cable as a second multi-function cable behaved in the same manner as the first.Once the device was charged the device immediately prompted "charge lead fault" and when charged, then prompted "charged lead fault".This indicates that if the shock button was pressed at this time, the device would not have delivered therapy as the impedance was outside the valid patient range.This occurs by design, as a shock would not be effective at that impedance range.The observed lead faults along with the high impedance measured during the discharge are an indication of poor coupling between the electrode pads and the patient's skin.However, this could not be firmly established as the electrode pads were disposed of at the facility and were not part of this investigation.Analysis of 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: 6583255
• Report Number: 1220908-2017-01110
• Device Sequence Number: 18850696
• Product Code: MKJ
• UDI-Device Identifier: 00847946004330
• UDI-Public: 00847946004330
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 05/02/2017

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: 05/05/2017
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 08/10/2017
• 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