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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION M SERIES; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION M SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number MSERIES CCT
Device Problem Failure to Discharge (1169)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
 
Event Description
Complainant alleged that during biomed testing the device was unable to discharge.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation; visual evaluation of the device found damage consistent with tampering.Due to the condition in which the device was received, root cause analysis could not be performed.The customer declined repair of the device and was returned to the customer labeled not for clinical use.Analysis for reports of this type has not identified an increase in trend.
 
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Brand Name
M SERIES
Type of Device
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
chelmsford MA
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key4987698
MDR Text Key23254982
Report Number1220908-2015-01998
Device Sequence Number1
Product Code DSK
UDI-Device Identifier00847946004859
UDI-Public00847946004859
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011865
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type unknown
Reporter Occupation Not Applicable
Type of Report Followup
Report Date 07/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMSERIES CCT
Device Catalogue NumberM SERIES
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/30/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received07/20/2015
Was Device Evaluated by Manufacturer? Yes
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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