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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP COMPLETE, SINGLE, R SERIES, ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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ZOLL MEDICAL CORPORATION ONESTEP COMPLETE, SINGLE, R SERIES, ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 8900-0224-01
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/29/2022
Event Type  malfunction  
Event Description
Rn pulled red tab to peel off plastic backing on the 2nd, blue pad with the ecg leads.While pulling the red tab, the pad ripped between the left lead and the red tab, exposing the ecg lead underneath.The plastic also felt harder to peel off than normal.Pads were quickly replaced.The patient did not need to be shocked at this moment so there was no delay in shock but a potential to have a delay.Lot #: 4221f.We do have device to send back.
 
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Brand Name
ONESTEP COMPLETE, SINGLE, R SERIES, ELECTRODES
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key14711671
MDR Text Key294129629
Report Number14711671
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 06/07/2022
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 Model Number8900-0224-01
Device Catalogue Number8900-0224-01
Device Lot Number4221F
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2022
Event Location Hospital
Date Report to Manufacturer06/16/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/16/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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