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

Model Number R SERIES

Device Problems Smoking (1585); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the device smoked and then a loud noise was heard after delivering the shock.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The device was put through extensive testing including defib/pacer stress testing, bench handling, and defib cycling without duplicating the report.Review of the device log shows pd core warning messages during pacing, a large difference between the measured impedances, and check patient messages before and after the delivered shock which is evidence of poor coupling between the patient and the electrodes pads being used.This poor coupling can be caused by various factors including but not limited to electrode placement, poor patient preparation, or just poor contact between the pad and patient.The poor coupling can lead to air pockets forming between the electrodes and the patient which can cause sparking, burning smell, and pop sound.The r series operator's guide states: do not use therapy or ecg electrodes if the gel is dried, separated, torn, or split from the foil; patient burns may result from using such electrodes.Poor adherence and/or air pockets under therapy electrodes can cause arcing and skin burns.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Zoll recommends that patients are cleaned and hair is clipped prior to applying electrode pads to assure good coupling of electrode to skin contact.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• 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: 18924164
• MDR Text Key: 337905904
• Report Number: 1220908-2024-01031
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017613
• UDI-Public: 00847946017613
• 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,Followup
• Report Date: 02/26/2024

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: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• 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