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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
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ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) Back to Search Results
Model Number 8011-0139-04
Device Problem Defective Component (2292)
Patient Problem No Information (3190)
Event Date 11/12/2018
Event Type  Injury  
Event Description
Adult internal defibrillator paddles did not function correctly.The button activation on the handpiece did not work and the set could not be used during cardiac surgery.A second set was obtained.The surgeon cut the cable, so they would not be reprocessed, so testing is hampered.Manufacturer response for autoclavable internal handles with integrated paddles, zoll (per site reporter).They will analyze for reported defects.
 
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Brand Name
AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES
Type of Device
DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill rd
chelmsford MA 01824 4105
MDR Report Key8260122
MDR Text Key133482152
Report Number8260122
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8011-0139-04
Device Catalogue Number8011-0139-04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2019
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer01/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age21170 DA
Patient Weight85
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