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

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem Necrosis (1971)

Event Date 08/24/2023

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 treat a patient (age & gender unknown), the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

Zoll medical corporation evaluated the clinical file and the device performed to specification.Review of the clinical file indicate that the end user initially had trouble acquiring a high-quality ecg signal.However, the patients ecg rhythm is eventually obtained, and the device can analyze and deliver energy.This indicates the device can perform all essential functions once all criteria have been met.The logs, and statements from the end users suggest that poor coupling was the cause of the lack of ecg signal.Once the coupling was improved, a signal was displayed, and the device capable of administering therapy.It is noteworthy to mention, the x series operator's guide states: preparing the patient for electrode application: the proper application of electrodes is essential for high quality ecg monitoring.Good contact between the electrodes and skin minimizes motion artifact and signal interference.Before applying the electrodes, prepare the patient's skin, as necessary, shave or clip off excess hair at electrode site, clean oily skin with an alcohol pad, and rub site briskly to dry.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: 17700779
• MDR Text Key: 322867309
• Report Number: 1220908-2023-03524
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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: 08/29/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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