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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP PEDIATRIC ELECTRODES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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ZOLL MEDICAL CORPORATION ONESTEP PEDIATRIC ELECTRODES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Catalog Number 8900-000219-01
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2016
Event Type  malfunction  
Event Description
Infant brought to emergency in full arrest. Defibrillator pads were placed. When cpr was started, the pads were not communicating the depth and rate of compressions. Cpr was continued without changing the pads. He never had a shockable rhythm as he did respond to 3 doses of epinephrine. A ct showed concerns for congenital heart disease. He was admitted to the picu and cardiology was consulted.
 
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Brand NameONESTEP PEDIATRIC ELECTRODES
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 & 271 mill road
chelmsford MA 01824
MDR Report Key6043243
MDR Text Key57932409
Report Number6043243
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/21/2018
Device Catalogue Number8900-000219-01
Device Lot Number2116
Other Device ID Number(01)00847946023348(17)180521(
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/05/2016
Event Location Hospital
Date Report to Manufacturer10/05/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/20/2016 Patient Sequence Number: 1
Treatment
CARDIAC DRUGS; DEFIBRILLATOR MONITOR WAS CHECKED AFTER THE EVENT
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