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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL ZOLL; INTERNAL DEFIBRILLATOR HANDLES
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ZOLL ZOLL; INTERNAL DEFIBRILLATOR HANDLES Back to Search Results
Catalog Number 8011050101
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2015
Event Type  malfunction  
Event Description
After steam sterilization inspection of the defibrillator internal electrode handles noted a linear crack beginning at the discharge button on the apex handle extending 8cm proximal down the handle towards the cable.It was noted and confirmed that the recommended and approved sterilization process and time was used.This is a subsequent failure of the same type with the handles failing near the discharge button.Handle retained for zoll evaluation.This is an additional event that was previously brought up with the manufacturer.This is still an ongoing event with no resolution.
 
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Brand Name
ZOLL
Type of Device
INTERNAL DEFIBRILLATOR HANDLES
Manufacturer (Section D)
ZOLL
269 & 271 mill road
chelmsford MA 01824
MDR Report Key5031066
MDR Text Key24094226
Report Number5031066
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Report Date 08/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number8011050101
Device Lot NumberV13A25491
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2015
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer08/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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