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

Model Number X SERIES

Device Problem Failure to Select Signal (1582)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device was unable to select energy level.Complainant indicated that the clinician performed cpr and swapped out the battery to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was 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 testing including bench handling, defib cycling, environmental stress testing, and internal inspection without duplicating a malfunction to the device.The device passed the final test procedure, was recertified, and returned to the customer.Review of the device log does confirm the event described by the customer.The device experienced a fault condition while the user attempted enter defib mode by pressing the energy select button.The device would not enter the defib mode and responded with an audible user advisory tone.The device is power cycled by the user, and was capable of discharging at 200 joules.No indication of a hard failure with the device based on the log review.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 9973860
• MDR Text Key: 188082953
• Report Number: 1220908-2020-01020
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946004354
• UDI-Public: 00847946004354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death