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U.S. Department of Health and Human Services

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

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ZOLL MEDICAL CORPORATION ZOLL R-SERIES ALS DEFIBRILLATOR/MONITOR/PACER AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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).
 
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Brand NameZOLL R-SERIES ALS DEFIBRILLATOR/MONITOR/PACER
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
chelmsford MA 01824
MDR Report Key12438840
MDR Text Key270684450
Report NumberMW5103766
Device Sequence Number1
Product Code MKJ
Number of Events Reported1
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
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberR-SERIES ALS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
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