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

Model Number X SERIES

Device Problem Arcing of Electrodes (2289)

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

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), a flash was seen from the associated electrode pads while performing the cardioversion.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation; instead, the electrode pads were returned, in the original packaging.Evaluation of the electrode pads showed the packaging had minor wrinkles.The pads were stuck to the correct side of the styrene liner making it easy to remove the pads without causing any damage.Visual inspection of the pads showed no signs of arcing.The pads also passed continuity testing.No burning odor was observed during the evaluation.Review of the provided data files confirmed the event started at 11:14, on 8/25/22.The log showed a single shock via synchronized cardioversion discharged at 260j with the joule setting at 200j and the patient impedance at 233 ohms.Based off the observed metric, the shock was delivered within specification.The value of the patient impedance appears to be high and is indicative of poor coupling.There are multiple factors outside of a device malfunction that could contribute to this condition.Some include, but are not limited to motion artifacts, or poor contact between the pads and the patient's skin.This report has been attributed to poor coupling.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: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 15450299
• MDR Text Key: 300242749
• Report Number: 1220908-2022-03471
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• 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
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• 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