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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE HANDLES, OVERMOLDED
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ZOLL MEDICAL CORPORATION AUTOCLAVABLE HANDLES, OVERMOLDED Back to Search Results
Model Number 1011-0140
Device Problem Failure to Discharge (1169)
Patient Problem Cardiac Arrest (1762)
Event Date 03/03/2015
Event Type  malfunction  
Event Description
Complainant alleged that while attempting to defibrillate a pt in cardiac arrest, the associated defibrillator failed to discharge with attached internal handles.Complainant indicated that the clinician obtained another set of internal handles to successfully treat the pt.Complainant indicated that there was no adverse effect to the pt due to the reported malfunction.
 
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
 
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Brand Name
AUTOCLAVABLE HANDLES, OVERMOLDED
Type of Device
AUTOCLAVABLE HANDLES
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
chelmsford MA
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key4645665
MDR Text Key5595656
Report Number1220908-2015-00660
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K032691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1011-0140
Device Catalogue Number8011-0140
Other Device ID Number00847946003197
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/24/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/04/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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