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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 M SERIES CCT
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The malfunction was observed during the incoming testing; however, after disassembling the device to determine root cause, the malfunction was no longer seen.The device was put through extensive testing without duplicating the malfunction.A flex cable was replaced as precaution.The device was recertified and returned to the customer.Analysis for reports of this type ahs not identified an increase in trend.
 
Event Description
Complainant alleged that during a routine shift check by a clinician, the device failed self-test.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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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 Key4987692
MDR Text Key23231277
Report Number1220908-2015-01966
Device Sequence Number1
Product Code DSK
UDI-Device Identifier00847946004811
UDI-Public00847946004811
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
Report Date 07/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM SERIES CCT
Device Catalogue NumberM SERIES
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/20/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/31/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2004
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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