MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL AUTOMATED DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/18/2022

Event Type  malfunction  

Event Description

The automated defibrillator was applied to the patient as instructed and the automated device indicated that a shock was advised after the device analyzed the patient's cardiac activity.In review of the cardiac rhythms displayed by the patient following the event, there was no shockable rhythm displayed but there was evidence of artifact.The device should not have advised to deliver a shock for artifact and is known to be able to analyze and differentiate between a shockable rhythm and artifact.The device was examined by the hospital htm department and not found to have any obvious defects or damage.

• Brand Name: ZOLL AUTOMATED DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 14257437
• MDR Text Key: 290448476
• Report Number: 14257437
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 180 DA
• Patient Sex: Male
• Patient Weight: 6 KG