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

Model Number	X SERIES
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/20/2020
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 treat a patient (age & gender unknown) for cardiac arrest, the device inappropriately shut down.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device passed full functionality, stress testing and multiple power cycles with no discrepancies found.The device appropriately displayed low battery and shut down warnings during testing.An internal inspection found no discrepancies that would contribute to the customer's report.The device was recertified and returned to the customer.Review of the device activity logs showed that the device was powered on continuously for 3 hours without any activity until a low battery warning is logged.A second low battery warning was seen approximately 30 minutes later followed by a shutdown warning.The device appears to power off 20 seconds after the shutdown warning message.The battery log confirms that this battery showed depleting capacity over the case duration.The logs show that the battery was fully depleted and the device performed to specification by warning the user with low battery warnings, shutdown warnings and a high pitched beep when the button was held down as described by the user.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: 10145866
• Report Number: 1220908-2020-01686
• Device Sequence Number: 2464556
• Product Code: MKJ
• UDI-Device Identifier: 00847946018139
• UDI-Public: 00847946018139
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/21/2020

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: 05/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/30/2020
• 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