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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); Improper Device Output (2953)
Patient Problem No Patient Involvement (2645)
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 during a biomed testing, the device was unable to obtain ecg signal via multifunction cable. Complainant indicated that there was no patient involvement in the reported malfunction.

 
Manufacturer Narrative

The device was returned to zoll medical corporation; visual evaluation of the device found damage consistent with tampering. Due to the condition in which the device was received, root cause analysis could not be performed. The device was repaired and returned to the customer. 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 Key5688824
MDR Text Key46210082
Report Number1220908-2016-01285
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 05/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2016
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 Number00847946000684
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/23/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2003
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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