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

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 01/16/2021

Event Type  Injury  

Event Description

An aed advised shock and the patient was subsequently shocked.The ecg analysis revealed a rhythm that should not have rendered an advisement to shock.Fda safety report id# (b)(4).

• Brand Name: ZOLL AED
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; chelmsford MA 01824 4105
• MDR Report Key: 11243456
• MDR Text Key: 229823231
• Report Number: MW5099052
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2021

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: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 66 YR
• Patient Weight: 86