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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR Back to Search Results
Model Number E SERIES
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Complainant alleged that during a routine shift check by a clinician, the device failed self test.Complainant indicated that there was no pt involvement in the reported malfunction.
 
Manufacturer Narrative
Zoll medical corp has not rec'd the product for eval and this complaint is still under investigation.
 
Manufacturer Narrative
The device was not returned to zoll medical corporation for eval.A zoll rep was onsite and evaluated the device.The device was put through extensive testing without duplicating the malfunction.The device was placed back into service.No trend is associated with reports of this type.
 
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Brand Name
E SERIES DEFIBRILLATOR
Type of Device
E SERIES
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
chelmsford MA
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key4856774
MDR Text Key5811130
Report Number1220908-2015-01497
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown,unknown
Reporter Occupation Not Applicable
Type of Report Initial,Followup
Report Date 05/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberE SERIES
Device Catalogue NumberE SERIES
Other Device ID Number00847946015732
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/26/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2006
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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