M SERIES MSERIES BI-PHASIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-15 for M SERIES MSERIES BI-PHASIC manufactured by Zoll Medical Corporation.

Event Text Entries

[138946102] The device was returned to zoll medical corporation for evaluation. During the investigation, the technician discovered that the customer attempted repair of the device. As a result of the device being tampered with, component root cause could not be firmly established for this report. A system interconnection flex cable was replaced as a precaution. The device was recertified and returned to the customer. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10


[138946103] Complainant alleged that during a routine shift check by a clinician, the device displayed a "defib pad short" message. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220908-2019-00624
MDR Report Key8425201
Date Received2019-03-15
Date of Report2019-02-22
Date Mfgr Received2019-02-22
Device Manufacturer Date2003-08-01
Date Added to Maude2019-03-15
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 Received2019-03-15
Returned To Mfg2019-02-28
Model NumberMSERIES BI-PHASIC
Catalog NumberM SERIES
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZOLL MEDICAL CORPORATION
Manufacturer Address269 MILL ROAD CHELMSFORD MA 01824 US 01824


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-15

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