R SERIES DEFIBRILLATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.

Event Text Entries

[185718561] 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


[185718562] Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable. Complainant indicated that the clinician obtained another device to continue treating the patient. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


[188145835] Zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed. The device was put through extensive testing without duplicating the report. The device was able to analyze correctly, and shock appropriately on multiple rhythms without issue with the customer's multifunction cable and a simulator. Without a clinical file. We cannot confirm th results of the patient event. No trend is associated with reports of this type.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220908-2020-00797
MDR Report Key9900413
Date Received2020-03-30
Date of Report2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2013-09-01
Date Added to Maude2020-03-30
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 NameR SERIES DEFIBRILLATOR
Generic NameDEFIBRILLATOR/PACEMAKER
Product CodeMKJ
Date Received2020-03-30
Returned To Mfg2020-03-18
Model NumberR SERIES
Catalog NumberR 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 2020-03-30

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