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

Model Number X SERIES

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device's defib output was out of specification.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned to zoll medical canada for evaluation.The customer's report was not replicated or confirmed.The device was put through extensive testing including defibrillation and pacer testing without duplicating the report.An internal inspection of the device found no discrepancies.The customer's returned multifunction cable passed all continuity testing.A review of the log files indicate the device recognized a short circuit during the actual delivery of energy.The electrode pads used at the time of the report were not returned as part of this investigation.However, the customer indicated they may have been applied the electrode pads incorrectly.The device was recertified and returned to the customer.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: 18282881
• MDR Text Key: 329943049
• Report Number: 1220908-2023-04717
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/16/2023

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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