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

Model Number R SERIES

Device Problem Inaccurate Synchronization (1609)

Patient Problem Ventricular Fibrillation (2130)

Event Date 06/30/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complainant alleged that during a synchronized cardioversion on a patient (age & gender unknown), the device discharged on a t-wave.Complainant indicated that the patient went into ventricular fibrillation as a result of the reported malfunction.Complainant indicated that the clinician performed cpr to continue treating the patient.

Manufacturer Narrative

Zoll medical united kingdom evaluated the device and the device performed to specification.The customer's report was not observed during evaluation of the device using the customer's returned accessories.The device passed functional stress testing, analyze, sync, and shock testing without duplicating the report.The device was recertified and returned to the customer.Review of the clinical log confirmed the device shocked on a t-wave.Prior to the shock, there is evidence of inconsistent r wave detection leading up to the shock.There was low amplitude, high frequency artifact on the ecg trace during the shock which could have affected the device's ability to detect an r wave.It is not known what caused the artifact, however, potential sources include motion artifact from the patient or the cable, poor connection between the pads and the patient, incorrect lead application, or the patient's inherent ecg waveform under the selected lead.Per the r series operator's guide "verify that markers are clearly visible on the monitor and their location is appropriate and consistent from beat to beat.If necessary, use the lead and size buttons to establish settings that yield the most consistent sync marker pattern." the device's ecg rhythm analysis and internal sync detect is performed by a sophisticated algorithm that can be affected by artifact that can cause the device to misidentify the patient's r wave.The operator's guide also states "inappropriate defibrillation or cardioversion of a patient may precipitate ventricular fibrillation, asystole, or other dangerous arrhythmias." no trend is associated with reports of this type.

• 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: 17470092
• MDR Text Key: 320497422
• Report Number: 1220908-2023-03013
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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