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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 BI-PHASIC
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2015
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 while attempting to treat a patient (age & gender unknown) the device's pacer output was not adjustable.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical for evaluation.The malfunction was observed and the control board was replaced to resolve the malfunction.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
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key5332978
MDR Text Key35063799
Report Number1220908-2015-03334
Device Sequence Number1
Product Code DRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990762
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMSERIES BI-PHASIC
Device Catalogue NumberM SERIES
Device Lot NumberN/A
Other Device ID Number00847946000684
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2006
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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