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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP R SERIES CPR PADS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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ZOLL MEDICAL CORPORATION ONESTEP R SERIES CPR PADS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Lot Number R2018-33
Patient Problems Cardiac Arrest (1762); Heart Block (4444); Respiratory Arrest (4461)
Event Date 07/01/2023
Event Type  malfunction  
Event Description
Zoll onestep cpr pads did not function as intended: the pads were applied immediately in the code (by an intensive care unit registered nurse), and they attempted to pace the patient who developed complete heart block, only to have lack of capture with the first set of pads.A second set was placed (after compressions and the like) with capture and successful transcutaneous (tc) pacing.Device given to zoll representative.
 
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Brand Name
ONESTEP R SERIES CPR PADS
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key17689497
MDR Text Key322716227
Report Number17689497
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/11/2023
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
Device Lot NumberR2018-33
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/11/2023
Event Location Hospital
Date Report to Manufacturer09/06/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/06/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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