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

Model Number R SERIES

Device Problem Self-Activation or Keying (1557)

Patient Problem Insufficient Information (4580)

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 treat a patient (age & gender unknown), the device self discharged.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 monitor a patient (age & gender unknown), the device performed the overnight self-test and self discharged delivering 36.4 joules the patient.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.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Please reference section b1, b2, b5, h1, and h6 (health effect impact code).Device evaluation: zoll medical corporation evaluated the device and the device performed to specification.The customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, impedance testing and defibrillation cycling without duplicating the report.The device was recertified and returned to the customer.Review of the activity log observed a shock event.The log indicated a shock was delivered after the device was manually charged to 30j and the shock button was depressed.It is noteworthy to mention, the r series is designed to provide a distinctive charge ready sound and display defib xxxj ready.The device will also have an illuminated shock button and audible shock tone.The user must press the shock button to deliver the energy.The automatic self-test will only occur if the device detects a shorted mfc cable.It is not possible for the r series to perform the automatic self-test if the device detects a patient impedance.Based on the evidence from the device log, this investigation is closed as unsubstantiated.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: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 17165892
• MDR Text Key: 317501963
• Report Number: 1220908-2023-02338
• 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: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

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: 06/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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