MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL R-SERIES ALS DEFIBRILLATOR/MONITOR/PACER; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number R-SERIES ALS

Device Problems No Display/Image (1183); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 08/31/2021

Event Type  Injury  

Event Description

When prepping a patient for a cardiac catheterization, pt was placed on the zoll monitor the monitor was in the "monitor" position but the screen was blank.The zoll monitor was then turned to the "defib" position and remained blank.The monitor was then turned to the "off" position and retried turning it to the "defib position" at which time the monitor delivered a shock to the patient through the defibrillation pads that had been applied to the patient.Fda safety report id # (b)(4).

• Brand Name: ZOLL R-SERIES ALS DEFIBRILLATOR/MONITOR/PACER
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA 01824
• MDR Report Key: 12438840
• MDR Text Key: 270684450
• Report Number: MW5103766
• Device Sequence Number: 1
• Product Code: MKJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/03/2021

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: Health Professional
• Device Model Number: R-SERIES ALS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2021
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 45