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

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem Asystole (4442)

Event Date 01/23/2024

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to monitor a 48-year-old patient (gender unknown), the device was unable to detect the attached electrode pads.Complainant indicated that the clinician obtained another device and electrode pads to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the data file of the customer's report was provided.Review of the data file found the device was displayed ecg through pads view at the beginning of the case while in defib mode.Then, the user turns on pacer mode.In pacer mode, the device goes to lead view automatically to capture pacing activity per design.The user attempted to reboot the device (56 seconds restart), and change/reinstall pads on the patient multiple times but they were unable to see the ecg signal on the patient due to the device being in the leads view for the rest of the case.After the user turned the device in pacer mode, the user never changed the lead view.The device was never power cycled long enough throughout the log to reset the lead view.Power cycle (2 minutes), any defib button press, or top left side button press after restart would have automatically changed the lead view of the device and would have seen the ecg signal.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
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 18631867
• MDR Text Key: 334441115
• Report Number: 1220908-2024-00494
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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
• Patient Age: 48 YR