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

Model Number	X SERIES
Medical Device Problem Codes	Unable to Obtain Readings (1516); Failure to Analyze Signal (1539)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/15/2020
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 defibrillate a female patient (age unknown) during cardiac arrest, the device was unable to analyze and did not recognize the attached electrode pads.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The device, multifunction cable, and cpr adapter were returned to zoll medical corporation; the customer's report was observed during review of the device's history log.The device was put through extensive debug and final testing without duplicating the report.The device passed the final test procedure, was recertified, and returned to the customer.The electrode pads used were not returned for evaluation.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: 10597093
• Report Number: 1220908-2020-03016
• Device Sequence Number: 16464273
• Product Code: MKJ
• UDI-Device Identifier: 00847946018139
• UDI-Public: 00847946018139
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 09/08/2020

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: 09/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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