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 Problem Shock (2072)

Event Date 09/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the clinician received an unintended delivery of energy.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 self discharged and the clinician received an unintended delivery of energy.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 code).Evaluation: the device was received at zoll medical corporation and the customer's report was unsubstantiated.Review of the device logs on the reported event date of (b)(6) 2020 showed that all four shock events were delivered successfully and manually via shock button presses.The r series records all button presses and errors the device experiences.The r series is designed to prevent a discharge until all criteria is met and the shock button is actuated.The device was functionally tested as part of the service zoll provides and passed.The device was recertified and returned to the customer.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
• MDR Report Key: 10630691
• MDR Text Key: 209947753
• Report Number: 1220908-2020-03159
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017170
• UDI-Public: 00847946017170
• Combination Product (y/n): N
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other