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

Model Number R SERIES

Device Problem Failure to Charge (1085)

Patient Problem Cardiac Arrest (1762)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device failed to charge.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

Zoll medical united kingdom evaluated the device and the device performed to specification.The device was put through extensive testing including functional testing, defib/pacer stress testing, bench handling, and defib cycling without duplicating the report.The device was recertified and returned to the customer.Review of the activity log showed the device detected a valid impedance.The device performed the first analysis and advised a shock and delivered the shock.The device conducted the next two analyses but did not recommend a shock and was advised to perform cpr.The user pressed the charge and shock buttons multiple times and the device neither charged the defib nor discharged the energy.The user powered the device on and off and the device was in aed mode.The user switched to manual mode to charge the device and deliver the energy.Review of the log indicated the user was unable to perform the charge operation due to the device being in aed mode.Per the design of the aed mode, the device is only able to charge at the selected energy (per the aed config) when the device detects a shockable rhythm and the zoll algorithm advises shock.The device does not charge energy by pressing the charge button in aed mode.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: 19217279
• MDR Text Key: 341437637
• Report Number: 1220908-2024-01696
• 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: 04/15/2024

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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