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

Model Number X SERIES

Device Problems Pacing Problem (1439); Defibrillation/Stimulation Problem (1573)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including functional testing, bench handling, and defib cycling without duplicating the report.The processor/bridge/pace board was replaced as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that during functional testing, the device displayed "defib disabled" and "pacer disabled" messages.Complainant did not indicate that there was any patient involvement in the reported malfunction.

• 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: 19114908
• MDR Text Key: 340263977
• Report Number: 1220908-2024-01285
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019259
• UDI-Public: 00847946019259
• 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: 03/26/2024

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: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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