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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP COMPLETE, SINGLE, R SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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ZOLL MEDICAL CORPORATION ONESTEP COMPLETE, SINGLE, R SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 8900-0224-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694); Blister (4537)
Event Date 11/15/2022
Event Type  Injury  
Event Description
Multiple reports received regarding zoll defibrillator pads that caused patient skin burns after shock.Patients admitted with skin intact.After applying and using the zoll defib pads, it was observed patient skin burns and tears as a result.Photos available.Event2: provider removed zoll pad from right lateral chest; noted what appeared as a blister that popped and is now weeping along the border of where the zoll pad was.Sales rep was informed.
 
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Brand Name
ONESTEP COMPLETE, SINGLE, R SERIES
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key15876632
MDR Text Key304430728
Report Number15876632
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 Biomedical Engineer
Type of Report Initial
Report Date 11/23/2022
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? Yes
Device Operator Health Professional
Device Model Number8900-0224-01
Device Catalogue Number8900-0224-01
Device Lot Number1122F
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2022
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer11/29/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/29/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other; Hospitalization;
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