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 2019-03-29 for M SERIES MSERIES BI-PHASIC manufactured by Zoll Medical Corporation.

Event Text Entries

[140309308] Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10


[140309309] Complainant alleged that during a routine shift check by a clinician, the device displayed a "poor pad contact" message. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


[142493865] The complainant was contacted for return of the device. The customer has responded and indicated the device was repaired and returend to service. The device will not be returning to zoll.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220908-2019-00796
MDR Report Key8464415
Date Received2019-03-29
Date of Report2019-03-08
Date Mfgr Received2019-03-08
Device Manufacturer Date2005-06-01
Date Added to Maude2019-03-29
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 Received2019-03-29
Model NumberMSERIES BI-PHASIC
Catalog NumberM SERIES
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-03-29

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