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

Model Number X SERIES

Device Problem Failure to Power Up (1476)

Patient Problem Necrosis (1971)

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 treat a patient (age & gender unknown), the device would not power up.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device performed to specification.The customer's report was not observed during evaluation.Review of the device logs confirms the device was used on (b)(6) 2021 until the battery was fully depleted and shutdown with a low battery and device shutdown warning.The device remains in this state until auxiliary power is applied on (b)(6) 2021.This confirms that there was no device malfunction, and the device operated as designed in the presence of a depleted battery.The zoll operator's guide (9650-002355-01) states to check batteries during daily shift checks and to carry a fully charged spare at all times.Analysis of 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
• MDR Report Key: 11807441
• MDR Text Key: 250022328
• Report Number: 1220908-2021-01591
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019778
• UDI-Public: 00847946019778
• Combination Product (y/n): N
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

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
• 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: 04/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death