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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 Death (1802)
Event Date 02/23/2019
Event Type  Death  
Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

 
Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed a "defib pad short" message. Complainant indicated that the clinician obtained another device to continue treating the patient. Complainant indicated that the patient subsequently expired.

 
Manufacturer Narrative

The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed. The device with multi-function cable were put through extensive testing including bench testing, impedance testing, defib cycle tests and various defib energies without duplicating the report. The device passed internal visual inspections. The device was recertified and returned to the customer. The electrodes involved were returned and visual inspection did not find any evidence that would inhibit the pads from shocking or causing a defib pad short condition. The electrodes were subjected to multiple discharge tests and the results were within specification. No data card was used during the event and no clinical logs were available as part of this investigation. Analysis of 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 Key8501570
MDR Text Key141524751
Report Number1220908-2019-00928
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK011865
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberMSERIES CCT
Device Catalogue NumberM SERIES
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/02/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/10/2019 Patient Sequence Number: 1
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