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

Model Number R SERIES

Device Problems Failure to Analyze Signal (1539); Incorrect Interpretation of Signal (1543)

Patient Problem Necrosis (1971)

Event Date 12/31/2022

Event Type  Death  

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 68-year-old male patient, the device was unable to analyze and issued a "no shock advised" prompt for a heart rhythm they believe was shockable.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device performed to specification.The device passed the final test and was recertified and returned to the customer.The customer's report for the device did not analyze was observed in the log.Review of the log showedwhile in monitor mode, the user pressed the analyze button, which prompted "select defib mode".Seconds later the user presses the analyze button again causing the device to prompt "select defib mode" once again.The user then proceeds to press the charge and shock button multiple times with no energy being delivered due to the device being still in monitor mode.The user presses the analyze button one more time before switching the device into manual defib mode.The user presses the analyze button and the device prompts "stand clear", and "no shock advised" indicating the device provided feedback while analyzing.It is important to note the device will only perform an analysis on the patient if it is in defib mode.The customer's report for "no shock advised" was observed in the visual data provide by the customer.The strip showed possible cpr being performed followed by an asystole (non-shockable rhythm).The analysis of rhythm from the device consists of three consecutive 3-second ecg rhythm analyses.If two or more of the three 3-second ecg analyses do not detect a shockable rhythm, the unit alerts the operator that no shock is advised.It is also important to note that ecg rhythm analysis does not warn of patient asystole to the user, but when detected will prompt no shock advised.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: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 16357226
• MDR Text Key: 309325176
• Report Number: 1220908-2023-00273
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019716
• UDI-Public: 00847946019716
• 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: 01/12/2023

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?: 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: 01/30/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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): Death
• Patient Age: 68 YR
• Patient Sex: Male