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

Model Number X SERIES

Device Problem Failure to Capture (1081)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 pace a patient (age & gender unknown), the device failed to capture the patient's heart rhythm.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b3, d1, d2, and d4 (model and catalog).Device evaluation: zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including functional testing, defib/pacer stress testing, bench handling, and defib cycling, using the returned one-step pacing cable, without duplicating the report.The device was recertified and returned to the customer.Review of the first clinical file observed the device displayed a clear ecg signal on pads before the device was turned to pacer mode.When the device was turned to pacer mode, the device detected an ecg lead-off message.Ecg lead off is an expected prompt if 1 or more ecg p leads are not properly coupled to the patient.The device detected valid impedance for electrode pad contact and the device was able to capture pacing activity until the end of the case.Per the design of the r-series, an ecg signal through leads is required to capture pace.Review of the second clinical file, showed the device was turned to pacer mode, the device went to p3 lead and captured pacing as expected.After 12 seconds, there was noise with the leads, but the pacer function was active and the device continued to capture pacing activity (with noise).After 3 minutes the user changed the lead view to p1 and no noise was seen and clean capture was observed.No trend is associated with reports of this type.

• 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: 19200290
• MDR Text Key: 341240402
• Report Number: 1220908-2024-01450
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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