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 2019-03-14 for M SERIES MSERIES BI-PHASIC manufactured by Zoll Medical Corporation.

Event Text Entries

[138771920] Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation. Please refer to the user medwatch report that zoll medical has received.
Patient Sequence No: 1, Text Type: N, H10


[138771921] Complainant alleged that while attempting to defibrillate a (b)(6) male patient, the device displayed a "defib pad short" message. Complainant indicated that the clinician obtained another device and electrode pads to continue treating the patient and received the same error. Complainant indicated that the patient subsequently expired. Please reference medwatch report 1220908-2019-00628 for the other defibrillator used in the event.
Patient Sequence No: 1, Text Type: D, B5


[140308352] This supplemental medwatch report is reporting the evaluation of the device. This supplemental medwatch report is also correcting information submitted on the initial medwatch report. The customer was contacted for return of the suspect product. The product has not been returned to zoll for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[145474621] Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed. The device was put through extensive testing which included bench handling, multiple 30 joules self-tests, shock testing at various joules settings utilizing the returned multifunction cable and continuity testing without duplicating the reported malfunction. The device's biphasic cable was replaced as a precaution. The device was recertified and returned to the customer. No trend is associated with reports of this type. Please refer to the attached user medwatch report that zoll medical has received.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220908-2019-00648
MDR Report Key8420089
Date Received2019-03-14
Date of Report2019-02-20
Date of Event2019-02-15
Date Facility Aware2019-02-15
Report Date2019-02-20
Date Reported to FDA2019-02-20
Date Reported to Mfgr2019-02-19
Date Mfgr Received2019-02-20
Device Manufacturer Date1999-06-01
Date Added to Maude2019-03-14
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 Received2019-03-14
Model NumberMSERIES BI-PHASIC
Catalog NumberM SERIES
Lot NumberNA
Device AvailabilityN
Device AgeDA
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
101. Death 2019-03-14

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