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

Model Number R SERIES

Device Problems Failure to Select Signal (1582); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

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

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device was unable to select the energy level.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (device problem code).Evaluation: the device was returned to zoll medical corporation.The customer's report was not replicated or confirmed.The device passed defib cycling and bench handling using known good internal and external paddles without duplicating the report.The device was recertified and returned to the customer.The multifunction cable and paddles used were not returned as part of this investigation.Review of the device log shows that the users were using internal paddles and increase the energy to the 50 joule max.After several attempts to increase the energy, there is a "check pads" message, and the defib is charged again and immediately discharged at 50 joules through external paddles.It is unable to be determined when the user attached external paddles and if they attemped to change the settings.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: 12489138
• MDR Text Key: 271936834
• Report Number: 1220908-2021-02994
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017200
• UDI-Public: 00847946017200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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: 09/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2020
• 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