MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION RESPONDER 2000, PACING, BRZ PORT; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number 2026109-004

Device Problem Failure to Charge (1085)

Patient Problem Necrosis (1971)

Event Date 07/19/2021

Event Type  Death  

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 (b)(6) year-old male patient, the device failed to charge.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the device log was provided.A review of the provided device log did confirm what appears to be patient use.However, the activity shows the first shock delivery at 22:59:08 and not 20:15 as reported.Defib mode is exited and entered again approximately a minute later.There are several minutes of what appears to be poor ecg signal messages, and the exiting/entering of defib mode, but there is no charge event seen during this time.There is also evidence of a second charge and shock event wherein the report is that no second shock was delivered.The log file is inconsistent with the reported series of events.It is unknown if during the timeframe of seeing possible signal issues and the toggling in and out of defib modes, a charge attempt was made and the device was not in defib mode.There does not appear to be any errors in the log file.However, without receipt of the device we are unable to determine root cause from the device log files.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: RESPONDER 2000, PACING, BRZ PORT
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 12387934
• MDR Text Key: 268800150
• Report Number: 2112020-2021-00852
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K052316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2026109-004
• Device Catalogue Number: 2026109-004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 75