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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 Deliver Shock/Stimulation (1133)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during functional testing, the device failed to discharge.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical italy and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling and defib discharge stress testing without duplicating the report.The device was recertified and returned to the customer.No trend is associated with reports of this type.
 
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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 Key12491198
MDR Text Key273111079
Report Number1220908-2021-02996
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K011865
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/27/2021
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 Other
Device Model NumberMSERIES CCT
Device Catalogue NumberM SERIES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/27/2021
Initial Date FDA Received09/17/2021
Supplement Dates Manufacturer Received08/27/2021
Supplement Dates FDA Received01/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2009
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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