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

Model Number R SERIES

Device Problem Inaccurate Synchronization (1609)

Patient Problem Arrhythmia (1721)

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to cardiovert a male patient, the device's sync-output time was incorrect.Complainant indicated that the patient's rhythm went into an arrhythmia.The patient was revived and recovered.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: the device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.An internal inspection found no discrepancies.No accessories were returned as part of this investigation and the clinical log is not available for review.The device was recertified and returned to the customer.Clinical data was not available but review of the strip suggests evidence of irregular and atypical beats, with some evidence of physiologic r-on-t wave (superimposition of the ectopic beat on the t wave of a preceding beat).In cases where qrs detection is unreliable, it is recommended that a different monitoring lead is chosen before starting a cardioversion procedure.Due to limitations in the strip and the ecg recorded, it is not possible to see exactly what triggered the device to identify an r wave and deliver energy.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: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 15185299
• MDR Text Key: 297500697
• Report Number: 1220908-2022-02958
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017521
• UDI-Public: 00847946017521
• 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: 07/18/2022

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?: 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: 07/26/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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): Other
• Patient Sex: Male