M SERIES MSERIES CCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-02 for M SERIES MSERIES CCT manufactured by Zoll Medical Corporation.

Event Text Entries

[101467905] Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


[101467906] Complainant alleged that during biomed testing, the device was unable to obtain ecg signal via multi-function cable. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


[103964295] The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty integrated circuit on the system board. The customer declined repair of the device. The device was labeled not for clinical use. And returned to the customer. Analysis for reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220908-2018-00610
MDR Report Key7310777
Date Received2018-03-02
Date of Report2018-02-12
Date Mfgr Received2018-02-12
Device Manufacturer Date2004-10-01
Date Added to Maude2018-03-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street269 MILL ROAD
Manufacturer CityCHELMSFORD MA 01824
Manufacturer CountryUS
Manufacturer Postal01824
Manufacturer Phone9784219552
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameM SERIES
Generic NameDEFIBRILLATOR/PACEMAKER
Product CodeDPS
Date Received2018-03-02
Returned To Mfg2018-02-22
Model NumberMSERIES CCT
Catalog NumberM SERIES
Lot NumberNA
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZOLL MEDICAL CORPORATION
Manufacturer Address269 MILL ROAD CHELMSFORD MA 01824 US 01824


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-02

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