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

Model Number R SERIES

Device Problems Self-Activation or Keying (1557); Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); Insufficient Information (4580)

Event Date 05/26/2023

Event Type  Injury  

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device self-discharged.Complainant alleged that the student paramedic attending the patient received an unintended delivery of energy from the device.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.The customer was unable to provide additional information regarding the adverse effects on the student paramedic due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned to zoll medical united kingdom for evaluation.The customer's report of "the device self-discharged" was not replicated or confirmed.A review of the device activity log shows the device analyzed and prompted "shock advised" and "press shock".The device recorded a shock button press.There is no evidence of the reported malfunction.The r series is not designed to deliver energy on its own in any mode (aed or manual); the user must always press the shock button.The customer's report of "the student paramedic attending the patient received an unintended delivery of energy from the device" was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The device activity log shows no evidence of the report.The r series operator's guide states for all personnel to stand clear of the patient prior to defibrillation discharge.The clinical log files were not available to review as part of this investigation.The device was recertified and returned to the customer.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: 17100813
• MDR Text Key: 316932366
• Report Number: 1220908-2023-02262
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• 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: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• 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