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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 Problems Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)
Patient Problem No Consequences Or Impact To Patient (2199)
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 indicated that while attempting to treat a patient (age & gender unknown) the device was unable to obtain an ecg signal via electrode pads. 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 corporation; the malfunction was observed and attributed to a loose component on the system board. The cause was determined to be related to oxidation of the plating on this 10 year old board. The system 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 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 Key5161824
MDR Text Key28951957
Report Number1220908-2015-02697
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK990762
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/20/2015
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
OTHER Device ID Number00847946004217
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/08/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2005
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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