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

Model Number R SERIES

Device Problems Sparking (2595); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2024

Event Type  malfunction  

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 defibrillate a patient (age & gender unknown), the device's defib output was out of specification and sparks were emitted from the electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the data file of the customer's report was provided.Review of the device log shows a sucessful first shock.However, the second shock has a large difference between the measured impedances which is evidence of poor coupling between the patient and the electrodes being used.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.Poor adherance and/or air under the electrodes can lead to the possibility of arcing and skin burns.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to defibrillate a 66-year-old male patient, the device's defib output was out of specification and sparks were emitted from the electrode pads.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

This supplemental medwatch report is correcting information submitted on the initial medwatch report.Please reference sections a2, a3a, b1, b2, b5, h1, and h6 (health effect clinical code).

• 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: 19158400
• MDR Text Key: 341003265
• Report Number: 1220908-2024-01508
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Male