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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 Unable to Obtain Readings (1516)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

 
Event Description

Complainant alleged that during functional testing, the device was unable to obtain an ecg signal via electrode pads. Complainant did not indicate that there was any patient involvement in the reported malfunction.

 
Manufacturer Narrative

The customer was contacted for return of the suspect product. The customer has responded and indicated the product will not be returning to zoll.

 
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Brand NameM SERIES
Type of DeviceDEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key8183940
MDR Text Key130991512
Report Number1220908-2018-03635
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK011865
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2018
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
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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