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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 Failure to Read Input Signal (1581)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 was unable to obtain an ecg signal. 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 and the customer's report was not replicated or confirmed. The device was put through extensive testing without duplicating the report. The device was recertified and returned to the customer. The multi-function cable passed all testing. No trend is associated with reports of this type.

 
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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 Key5075279
MDR Text Key25717309
Report Number1220908-2015-02280
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 08/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2015
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 Number00847946003944
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/01/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2003
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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